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
181d
Avg (2y)
1976
Since
11242 Chemistry devices
5076–5100 of 11242
Cleared Jun 03, 1994
STAT FAX 2600
K941394 · Awareness Technology, Inc.
JQW · Station, Pipetting And Diluting, For Clinical Use · 73d
Cleared Jun 02, 1994
APOLIPOPROTIEN B (APO B)
K932603 · Sigma Diagnostics, Inc.
JHN · Turbidimetric Method, Lipoproteins · 370d
Cleared Jun 02, 1994
APOLIPOPROTIEN A-1 (APO A-1)
K932606 · Sigma Diagnostics, Inc.
JHN · Turbidimetric Method, Lipoproteins · 370d
Cleared Jun 02, 1994
LIPASE REAGENT SYSTEM
K940457 · Medical Diagnostic Technologies, Inc.
CET · Olive Oil Emulsion (turbidimetric), Lipase · 121d
Cleared Jun 02, 1994
PREDICTOR HOME PREGNANCY TEST
K940637 · Organon Teknika Corp.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 108d
Cleared Jun 02, 1994
ACCESS PROLACTIN
K941175 · Bio-Rad Laboratories, Inc.
CFT · Radioimmunoassay, Prolactin (lactogen) · 80d
Cleared May 27, 1994
ABL SYSTEM 620
K935121 · Radiometer America, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 212d
Cleared May 27, 1994
ABL5 BLOOD GAS SYSTEM
K935655 · Radiometer America, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 184d
Cleared May 27, 1994
ULTRAFREE-CL
K941326 · Millipore Corp.
JJH · Clinical Sample Concentrator · 70d
Cleared May 23, 1994
AUTO DELFIA
K935047 · Wallac OY
KHO · Fluorometer, For Clinical Use · 214d
Cleared May 23, 1994
CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF
K940810 · Ciba Corning Diagnostics Corp.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 90d
Cleared May 19, 1994
DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G
K941159 · International Technidyne Corp.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 69d
Cleared May 17, 1994
LIPASE-PS ASSAY PROCEDURE NO. 805
K941085 · Sigma Diagnostics, Inc.
CHI · Lipase-esterase, Enzymatic, Photometric, Lipase · 70d
Cleared May 17, 1994
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
K941313 · Stanbio Laboratory
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 60d
Cleared May 13, 1994
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317 · Ciba Corning Diagnostics Corp.
JFT · Fluorometric, Cortisol · 254d
Cleared May 13, 1994
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
K941764 · Hi Chem, Inc.
CJY · Azo Dye, Calcium · 45d
Cleared May 10, 1994
GLUCOFILM TEST STRIPS
K936212 · Heraeus Kulzer, Inc.
CGA · Glucose Oxidase, Glucose · 133d
Cleared May 09, 1994
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
K935014 · Diagnostic Systems Laboratories, Inc.
JKC · Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) · 201d
Cleared May 09, 1994
URINARY ALBUMIN TEST PACK
K936202 · Dupont Medical Products
JIQ · Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) · 131d
Cleared May 03, 1994
ACE CLINICAL CHEMISTRY SYSTEM
K940267 · Schiapparelli Biosystems, Inc.
KXT · Enzyme Immunoassay, Digoxin · 102d
Cleared May 03, 1994
SYNERMED AMYLASE REAGENT KIT
K941091 · Synermed, Inc.
JFJ · Catalytic Methods, Amylase · 56d
Cleared May 03, 1994
LIQUID ALT(SGPT) REAGENT SET
K941287 · Pointe Scientific, Inc.,
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 47d
Cleared May 02, 1994
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER
K940058 · Sherwood Medical Co.
GIM · Tubes, Vacuum Sample, With Anticoagulant · 117d
Cleared May 02, 1994
LIQUID AST (SGOT)REAGENT SET
K941132 · Pointe Scientific, Inc.,
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 54d
Cleared Apr 26, 1994
CARDIAC T ELISA TROPONIN-T
K924392 · Boehringer Mannheim Corp.
MMI · Immunoassay Method, Troponin Subunit · 603d

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All categories 11242 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 473 JJX Single (specified) Analyte Controls (assayed And Unassayed) 386 CGA Glucose Oxidase, Glucose 302 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 249 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 176 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 157 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143