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
11235 Chemistry devices
4576–4600 of 11235
Cleared Apr 03, 1996
LIPID CONTROL
K960862 · Medical Analysis Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 33d
Cleared Apr 01, 1996
TRUE TRIGLYCERIDE
K960088 · Diagnostic Chemicals , Ltd.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 81d
Cleared Apr 01, 1996
UNIMARK MIDSTREAM PREGNANCY TEST STICK
K960174 · Biotech Atlantic, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 76d
Cleared Mar 29, 1996
HICHEM BUN/UREA REAGENT KIT
K960115 · Elan Pharma, Inc.
CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 78d
Cleared Mar 29, 1996
VACUTAINER BRAND PLUS SERUM & SST TUBES
K960250 · Becton Dickinson Vacutainer Systems
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 73d
Cleared Mar 29, 1996
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY
K960274 · Orgentec
JIR · Indicator Method, Protein Or Albumin (urinary, Non-quant.) · 70d
Cleared Mar 29, 1996
ACCESS FREE T3 ASSAY
K960913 · Bio-Rad Laboratories, Inc.
CDP · Radioimmunoassay, Total Triiodothyronine · 23d
Cleared Mar 28, 1996
ACTIVE CROSSLAPS ELISA
K960171 · Diagnostic Systems Laboratories, Inc.
JMM · Column Chromatography & Color Development, Hydroxyproline · 72d
Cleared Mar 22, 1996
BEST PREGNANCY TEST
K953606 · Ameritek, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 233d
Cleared Mar 22, 1996
DOCUMENT TDM ULTRA ASSAYED CONTROL
K960244 · Casco Standards
DIF · Drug Mixture Control Materials · 66d
Cleared Mar 20, 1996
LXN FRUCTOSAMINE TEST
K955629 · Lxn Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 100d
Cleared Mar 19, 1996
ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
K955353 · Tcpi, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 119d
Cleared Mar 19, 1996
PLATFORM ONESTEP PREGNANCY HOME TEST
K960117 · Syntron Bioresearch, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 68d
Cleared Mar 19, 1996
VIVASPIN 4 10,000 MW
K960298 · Vivascience, Inc.
JJH · Clinical Sample Concentrator · 57d
Cleared Mar 19, 1996
T-3 MICROWELL EIA MODEL 7013
K960412 · Biomerica, Inc.
CDP · Radioimmunoassay, Total Triiodothyronine · 50d
Cleared Mar 19, 1996
SELFCARE EARLY PREGNANCY TEST
K960436 · Selfcare, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 48d
Cleared Mar 13, 1996
ALBUMIN
K955781 · Derma Media Lab., Inc.
CIX · Bromcresol Green Dye-binding, Albumin · 83d
Cleared Mar 13, 1996
CALCIUM REAGENT
K955939 · Derma Media Lab., Inc.
CIC · Cresolphthalein Complexone, Calcium · 83d
Cleared Mar 13, 1996
TOTAL BILIRUBIN REAGENT
K955940 · Derma Media Lab., Inc.
CIG · Diazo Colorimetry, Bilirubin · 83d
Cleared Mar 12, 1996
SYSCON TURMOR MARKER CONTROL
K955812 · Scantibodies Laboratory, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 77d
Cleared Mar 12, 1996
TOTAL PROTEIN REAGENT
K955936 · Derma Media Lab., Inc.
CEK · Biuret (colorimetric), Total Protein · 82d
Cleared Mar 12, 1996
INORGANIC PHOSPHORUS REAGENT
K955937 · Derma Media Lab., Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 82d
Cleared Mar 12, 1996
CREATININE REAGENT
K955938 · Derma Media Lab., Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 82d
Cleared Mar 11, 1996
URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
K954977 · Teco Diagnostics
JRE · Refractometer For Clinical Use · 147d
Cleared Mar 11, 1996
ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS
K960085 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 60d

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All categories 11235 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 469 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