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
11241 Chemistry devices
4976–5000 of 11241
Cleared Nov 10, 1994
VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE
K944566 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 50d
Cleared Nov 08, 1994
CHEMSTRIP MINI UA URINE ANALYZER
K943592 · Boehringer Mannheim Corp.
KQO · Automated Urinalysis System · 106d
Cleared Nov 04, 1994
SIGMA GLUCOSE REAGENT
K933694 · Sigma Chemical Co.
CGA · Glucose Oxidase, Glucose · 463d
Cleared Nov 04, 1994
CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,
K944923 · Clinical Controls, Inc.
JJT · Enzyme Controls (assayed And Unassayed) · 29d
Cleared Nov 02, 1994
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
K943811 · Biomerieux Vitek, Inc.
CFT · Radioimmunoassay, Prolactin (lactogen) · 89d
Cleared Nov 02, 1994
FLUIDS PACK
K944516 · Alko Diagnostic Corp.
JIT · Calibrator, Secondary · 48d
Cleared Nov 02, 1994
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
K944562 · Microgenics Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 64d
Cleared Oct 31, 1994
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3
K935599 · Clinical Controls, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 346d
Cleared Oct 31, 1994
ROCHE REAGENT
K941573 · Roche Diagnostic Systems, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 214d
Cleared Oct 31, 1994
IMMULITE SHBG
K941797 · Diagnostic Products Corp.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 202d
Cleared Oct 31, 1994
FOLIC ACID
K943705 · Diagnostic Products Corp.
CGN · Acid, Folic, Radioimmunoassay · 91d
Cleared Oct 31, 1994
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
K943780 · Heraeus Kulzer, Inc.
JJW · Urinalysis Controls (assayed And Unassayed) · 89d
Cleared Oct 27, 1994
MONOJECT SAMPLETTE SEPARATOR TUBE
K941291 · Sherwood Medical Co.
GIO · Tube, Collection, Capillary Blood · 224d
Cleared Oct 25, 1994
PRO-STEP LH OVULATION PREDICTION TEST
K943252 · Disease Detection International, Inc.
CEP · Radioimmunoassay, Luteinizing Hormone · 111d
Cleared Oct 25, 1994
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
K944426 · Princeton BioMeditech Corp.
JHI · Visual, Pregnancy Hcg, Prescription Use · 43d
Cleared Oct 21, 1994
CEDIA DAU AMPHETAMINES ASSAY
K943993 · Microgenics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 66d
Cleared Oct 20, 1994
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
K942610 · Eastman Kodak Company
LFM · Enzyme Immunoassay, Digitoxin · 140d
Cleared Oct 20, 1994
CEDIA T4 MAB ASSAY
K943019 · Microgenics Corp.
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 118d
Cleared Oct 20, 1994
DMA GLUCOSE (OXIDASE) PROCEDURE
K943241 · Data Medical Associates, Inc.
CGA · Glucose Oxidase, Glucose · 106d
Cleared Oct 20, 1994
MRX MICROPLATE READER
K943701 · Dynatech Laboratories, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 83d
Cleared Oct 20, 1994
AVL OPTI PH/BLOOD GAS ANALYZER
K944089 · Avl Scientific Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 59d
Cleared Oct 06, 1994
ACE CEDIA PHENOBARBITAL ASSAY
K942501 · Schiapparelli Biosystems, Inc.
DLZ · Enzyme Immunoassay, Phenobarbital · 135d
Cleared Oct 04, 1994
MULTI ANALYTE LINEARITY SET
K936245 · Teco Diagnostics
JJY · Multi-analyte Controls, All Kinds (assayed) · 278d
Cleared Oct 04, 1994
ROCHE AMMONIA (VARIOUS)
K942048 · Roche Diagnostic Systems, Inc.
DKB · Calibrators, Drug Mixture · 159d
Cleared Oct 04, 1994
HITACHI 914 ANALYZER
K942364 · Boehringer Mannheim Corp.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 140d

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All categories 11241 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) 385 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