FDA Review Panel · CH

FDA 510(k) Chemistry Devices

FDA 510(k) Chemistry Devices - Regulatory Overview

FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.

This category includes:

  • Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
  • Point-of-care test systems - rapid diagnostics for hospital and home use
  • Reagents and calibrators - consumables used with automated analyzers
  • Urinalysis systems - dipstick readers and urine sediment analyzers

Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.

13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
1076–1100 of 13257
Cleared Nov 06, 2013
UNISTRIP 1
K113135 · Unistrip Technologies, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 744d
Cleared Nov 05, 2013
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
K122338 · Prodigy Diabetes Care, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 460d
Cleared Oct 28, 2013
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
K132462 · Hitachi Chemical Diagnostics, Inc.
CDN · Urease, Photometric, Urea Nitrogen · 82d
Cleared Oct 25, 2013
IMMULITE 2000
K133124 · Siemens Healthcare Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 25d
Cleared Oct 25, 2013
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
K132227 · Bio-Rad Laboratories
JJY · Multi-analyte Controls, All Kinds (assayed) · 100d
Cleared Oct 24, 2013
RIGHTEST CONTROL SOLUTION
K133003 · Bionime Corporation
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Oct 24, 2013
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K132338 · Delbio Incorporation
NBW · System, Test, Blood Glucose, Over The Counter · 90d
Cleared Oct 23, 2013
RANDOX CSF CONTROLS LEVELS 2 AND 3
K132156 · Randox Laboratories, Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 104d
Cleared Oct 22, 2013
IMMULITE 2000
K133128 · Siemens Healthcare Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 22d
Cleared Oct 22, 2013
MULTICHEM S PLUS / S PLUS (ASSAYED)
K132751 · Techno-Path Manufacturing , Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 49d
Cleared Oct 18, 2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · Roche Diagnostics
JHY · Colorimetric Method, Cpk Or Isoenzymes · 64d
Cleared Oct 18, 2013
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE
K130213 · Lumiquick Diagnostics, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 262d
Cleared Oct 17, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
K132272 · Glooko, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 87d
Cleared Oct 17, 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · Nova Biomedical Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 189d
Cleared Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
K132664 · Siemens Healthcare Diagnostics, Inc.
CJW · Bromcresol Purple Dye-binding, Albumin · 50d
Cleared Oct 15, 2013
MULTICHEM U
K131993 · Techno-Path Manufacturing , Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 109d
Cleared Oct 11, 2013
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · Roche Diagnostics Operations, Inc.
LFR · Glucose Dehydrogenase, Glucose · 151d
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662 · Siemens Healthcare Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 125d
Cleared Oct 09, 2013
AU BICARBONATE REAGENT
K131546 · Beckman Coulter Ireland, Inc.
KHS · Enzymatic, Carbon-dioxide · 133d
Cleared Oct 04, 2013
PATHFAST CK-MB-II CALIBRATORS
K130628 · Mitsubishi Chemical Medience Corporation
JIT · Calibrator, Secondary · 210d
Cleared Oct 02, 2013
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
K131975 · Alfa Wassermann Diagnostic Technologies, Inc.
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 96d
Cleared Oct 01, 2013
ACCESS TOTAL BHCG (5TH IS)
K130020 · Beckman Coulter, Inc.
DHA · System, Test, Human Chorionic Gonadotropin · 271d
Cleared Sep 26, 2013
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
K122370 · Bayer Healthcare
NBW · System, Test, Blood Glucose, Over The Counter · 416d
Cleared Sep 25, 2013
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
K121790 · Beckman Coulter, Inc.
MMI · Immunoassay Method, Troponin Subunit · 464d
Cleared Sep 20, 2013
MULTICHEM IA AND IA PLUS
K132091 · Techno-Path Manufacturing , Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 74d

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All categories 13257 JJY Multi-analyte Controls, All Kinds (assayed) 554 NBW System, Test, Blood Glucose, Over The Counter 513 JJX Single (specified) Analyte Controls (assayed And Unassayed) 409 CGA Glucose Oxidase, Glucose 391 JHI Visual, Pregnancy Hcg, Prescription Use 359 JIX Calibrator, Multi-analyte Mixture 271 CIG Diazo Colorimetry, Bilirubin 234 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 226 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 JIT Calibrator, Secondary 224 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 223 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 199 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 183 JGS Electrode, Ion Specific, Sodium 162