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
5001–5025 of 11241
Cleared Oct 04, 1994
KOVA LIQUA-TROL
K942853 · Hycor Biomedical, Inc.
JJW · Urinalysis Controls (assayed And Unassayed) · 110d
Cleared Oct 04, 1994
HICHEM ENZYME VERIFIER KIT
K943684 · Hi Chem, Inc.
JJT · Enzyme Controls (assayed And Unassayed) · 67d
Cleared Oct 04, 1994
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
K943925 · Quantimetrix Corp.
JJR · Electrolyte Controls (assayed And Unassayed) · 53d
Cleared Oct 03, 1994
DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM
K941146 · Dupont Medical Products
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 207d
Cleared Sep 20, 1994
GAMMA-BCT INTACT PTH
K942369 · Immunodiagnostic Systems , Ltd.
CEW · Radioimmunoassay, Parathyroid Hormone · 125d
Cleared Sep 20, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
K942619 · Syva Co.
LFM · Enzyme Immunoassay, Digitoxin · 117d
Cleared Sep 20, 1994
CREATININE-PO REAGENT KIT
K943924 · Synermed, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 39d
Cleared Sep 14, 1994
INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT
K941807 · Intersect Systems, Inc.
CHG · Acid, Phosphoric-tungstic (spectrophotometric), Chloride · 155d
Cleared Sep 14, 1994
BILIRUBIN PLUS/PEDIATRIC CONTROLS
K943290 · Medi-Tech, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 68d
Cleared Sep 14, 1994
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT
K943754 · Bionostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 43d
Cleared Sep 09, 1994
URINE REAGENT STRIP-3 PARAMETERS
K940469 · Teco Diagnostics
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 219d
Cleared Sep 09, 1994
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222
K940679 · Helena Laboratories
JHO · Electrophoretic Separation, Lipoproteins · 212d
Cleared Sep 09, 1994
DUPONT DIMENSION AMYLASE METHOD
K942640 · Dupont Medical Products
JFJ · Catalytic Methods, Amylase · 98d
Cleared Sep 09, 1994
AVL 988-4 ELECTROLYTE ANALYZER
K943702 · Avl Scientific Corp.
JFP · Electrode, Ion Specific, Calcium · 42d
Cleared Sep 07, 1994
ACCESS(R) TOTAL T3
K940833 · Bio-Rad Laboratories, Inc.
CDP · Radioimmunoassay, Total Triiodothyronine · 196d
Cleared Sep 07, 1994
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
K941168 · Incstar Corp.
CHP · Radioimmunoassay, Estradiol · 177d
Cleared Sep 07, 1994
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic
CEP · Radioimmunoassay, Luteinizing Hormone · 96d
Cleared Sep 06, 1994
DELFIA SHBG KIT
K940449 · Wallac OY
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 217d
Cleared Sep 06, 1994
FLUIDS PACK FOR CORING 238
K940760 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 200d
Cleared Sep 06, 1994
DMA MICROPROTEIN PROCEDURE
K942424 · Data Medical Associates, Inc.
CEK · Biuret (colorimetric), Total Protein · 109d
Cleared Sep 02, 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
K942114 · Roche Diagnostic Systems, Inc.
DIF · Drug Mixture Control Materials · 122d
Cleared Aug 26, 1994
ROCHE REAGENT FOR CREATININE
K941837 · Roche Diagnostic Systems, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 135d
Cleared Aug 26, 1994
CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET
K942284 · Creative Laboratory Products, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 107d
Cleared Aug 26, 1994
AURAFLEX SYSTEMS
K942443 · Organon Teknika Corp.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 95d
Cleared Aug 24, 1994
CK-MB ASSAY, CATALOGUE NUMBER 317-10
K942773 · Diagnostic Chemicals , Ltd.
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 72d

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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