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
11244 Chemistry devices
5201–5225 of 11244
Cleared Dec 03, 1993
COCAINE METABOLITE EIA ASSAY MODIFICATION
K935016 · Diagnostic Reagents, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 46d
Cleared Dec 02, 1993
NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
K932406 · Nuclear Diagnostics, Inc.
JNO · N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin · 203d
Cleared Dec 02, 1993
REAGENTS FOR COBAS ISE MODULE
K934701 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 63d
Cleared Nov 26, 1993
SPQ MALB CONTROL LEVEL II
K934521 · Incstar Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 70d
Cleared Nov 17, 1993
T3 UPTAKE CHEMILUMINESCENCE ASSAY
K926220 · Nichols Institute Diagnostics
KHQ · Radioassay, Triiodothyronine Uptake · 342d
Cleared Nov 17, 1993
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
K932778 · Boehringer Mannheim Corp.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 162d
Cleared Nov 16, 1993
SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA
K925093 · Beckman Instruments, Inc.
JJF · Analyzer, Chemistry, Micro, For Clinical Use · 405d
Cleared Nov 16, 1993
STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
K932049 · Stanbio Laboratory
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 203d
Cleared Nov 16, 1993
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
K933425 · Sigma Diagnostics, Inc.
DKC · Alcohol Control Materials · 126d
Cleared Nov 16, 1993
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
K934039 · Intersect Systems, Inc.
LBR · Ldl & Vldl Precipitation, Hdl · 90d
Cleared Nov 16, 1993
OLYMPUS CREATININE REAGENT
K934361 · Olympus Corp.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 69d
Cleared Nov 10, 1993
GLUCOSTIX REAGENT STRIPS
K926362 · Heraeus Kulzer, Inc.
CGA · Glucose Oxidase, Glucose · 324d
Cleared Nov 10, 1993
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
K930322 · Heraeus Kulzer, Inc.
CEC · Radioimmunoassay, Free Thyroxine · 292d
Cleared Nov 09, 1993
AIA-PACK E2 ASSAY
K932084 · Tosoh Medics, Inc.
CHP · Radioimmunoassay, Estradiol · 193d
Cleared Nov 09, 1993
IRON/UIBC REAGENT
K932517 · Sigma Diagnostics, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 168d
Cleared Nov 09, 1993
CHOLESTECH L.D.X. SYSTEM
K932727 · Cholestech Corp.
CGA · Glucose Oxidase, Glucose · 158d
Cleared Nov 05, 1993
AMYLASE REAGENT SET (KINETIC)
K931080 · Teco Diagnostics
JFJ · Catalytic Methods, Amylase · 248d
Cleared Nov 05, 1993
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM
K932467 · Instrumentation Laboratory CO
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 165d
Cleared Nov 05, 1993
SYNELISA PROGESTERONE
K933128 · Elias U.S.A., Inc.
JLS · Radioimmunoassay, Progesterone · 130d
Cleared Nov 05, 1993
ACCESS VITAMIN B12 ASSAY
K933142 · Bio-Rad Laboratories, Inc.
CDD · Radioassay, Vitamin B12 · 130d
Cleared Nov 05, 1993
OLYMPUS CHLORIDE REAGENT, MODIFICATION
K934136 · Olympus Corp.
CHJ · Mercuric Thiocyanate, Colorimetry, Chloride · 78d
Cleared Nov 05, 1993
N-ASSAY TIA MICROALBUMIN CALIBRATOR SET
K934143 · Crestat Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 73d
Cleared Oct 29, 1993
ELS 1000
K933548 · Bio-Tek Instruments, Inc.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 101d
Cleared Oct 28, 1993
DMA AMYLASE PROCEDURE
K931559 · Data Medical Associates, Inc.
CIW · Starch-dye Bound Polymer, Amylase · 212d
Cleared Oct 28, 1993
CARDIO REP RECOMBINANT CK ABNORMAL CONTROL
K932442 · Helena Laboratories
JJT · Enzyme Controls (assayed And Unassayed) · 161d

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All categories 11244 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) 387 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