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.

13237
Total
13205
Cleared
191d
Avg (2y)
1976
Since
11183 Chemistry devices
1076–1100 of 11183
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
Cleared Sep 17, 2013
ABL90 FLEX ANALYZER
K131988 · Radiometer Medical Aps
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 81d
Cleared Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249 · Siemens Healthcare Diagnostics, Inc.
CEC · Radioimmunoassay, Free Thyroxine · 56d
Cleared Sep 10, 2013
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K123567 · Church & Dwight Co., Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 294d
Cleared Sep 06, 2013
LIAISON XL HCG
K131037 · DiaSorin, Inc.
DHA · System, Test, Human Chorionic Gonadotropin · 144d
Cleared Sep 05, 2013
LIAISON 25 TOTAL-D
K132492 · DiaSorin, Inc.
MRG · System, Test, Vitamin D · 27d
Cleared Aug 30, 2013
ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
K131363 · Cilag GmbH International
NBW · System, Test, Blood Glucose, Over The Counter · 109d
Cleared Aug 26, 2013
FIRST RESPONSE EARLY RESULT PREGNANCY TEST
K123436 · Church & Dwight Co., Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 292d
Cleared Aug 23, 2013
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
K130244 · Delbio Incorporation
NBW · System, Test, Blood Glucose, Over The Counter · 204d
Cleared Aug 23, 2013
VANISHPOINT BLOOD COLLECTION SET
K122355 · Retractable Technologies, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 385d
Cleared Aug 22, 2013
OPTI CCA-TS2
K131126 · Opti Medical Systems, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 122d
Cleared Aug 21, 2013
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM
K130696 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 160d
Cleared Aug 20, 2013
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
K123563 · Magellan Diagnostics
DOF · Lead, Atomic Absorption · 274d
Cleared Aug 20, 2013
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
K122766 · Microgenics Corp.
OUF · Everolimus Immunoassay · 344d
Cleared Aug 19, 2013
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
K131488 · Alfa Wassermann Diagnostics Technologies, LLC
CIX · Bromcresol Green Dye-binding, Albumin · 88d
Cleared Aug 15, 2013
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
K132072 · Nipro Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 43d
Cleared Aug 15, 2013
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
K131351 · Alfa Wassermann Diagnostic Technologies, LLC
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 97d
Cleared Aug 15, 2013
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
K122181 · Visgeneer, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 388d
Cleared Aug 14, 2013
ACE -GT REAGENT
K131515 · Alfa Wassermann
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 78d
Cleared Aug 09, 2013
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
K131419 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 85d
Cleared Aug 09, 2013
ACCU-CHEK AVIVA PLUS TEST STRIP
K131029 · Roche Diagnostics Operations, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 119d

Looking for a specific chemistry device? Search by device name, K-number or manufacturer.

Search all Chemistry 510(k) devices

Filter by Product Code

All categories 11183 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 455 JJX Single (specified) Analyte Controls (assayed And Unassayed) 382 CGA Glucose Oxidase, Glucose 298 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 246 CIG Diazo Colorimetry, Bilirubin 216 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 175 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 156 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143