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
11260 Chemistry devices
5801–5825 of 11260
Cleared Nov 08, 1991
TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
K913371 · Creative Laboratory Products, Inc.
JIT · Calibrator, Secondary · 102d
Cleared Nov 07, 1991
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357 · Lifescan, Inc.
CGA · Glucose Oxidase, Glucose · 101d
Cleared Nov 07, 1991
TRIGLYCERIDES REAGENT SET
K914609 · Sterling Diagnostics, Inc.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 21d
Cleared Nov 05, 1991
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32
K913764 · Em Diagnostic Systems, Inc.
JGJ · Photometric Method, Magnesium · 75d
Cleared Oct 31, 1991
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
K912807 · Em Diagnostic Systems, Inc.
JFY · Enzymatic Method, Creatinine · 128d
Cleared Oct 31, 1991
SODIUM REAGENT SET
K914039 · Sterling Diagnostics, Inc.
CEI · Uranyl Acetate/zinc Acetate, Sodium · 51d
Cleared Oct 30, 1991
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172
K913058 · Helena Laboratories
CEF · Electrophoretic, Protein Fractionation · 112d
Cleared Oct 30, 1991
PHOSPHOLIPID REAGENT SET
K914040 · Sterling Diagnostics, Inc.
JNT · Chromatographic, Phospholipids · 50d
Cleared Oct 30, 1991
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL
K914469 · Cholestech Corp.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 23d
Cleared Oct 25, 1991
VENTREX COATED TUBE INTACT PTH
K913434 · Ventrex Laboratories, Inc.
CEW · Radioimmunoassay, Parathyroid Hormone · 85d
Cleared Oct 25, 1991
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · Em Diagnostic Systems, Inc.
CIG · Diazo Colorimetry, Bilirubin · 81d
Cleared Oct 25, 1991
MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER
K913590 · Dynatech Laboratories, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 74d
Cleared Oct 25, 1991
CIBA CORNING ACS T3 IMMUNOASSAY
K913646 · Ciba Corning Diagnostics Corp.
CDD · Radioassay, Vitamin B12 · 70d
Cleared Oct 25, 1991
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF
K914240 · Unipath , Ltd.
JHI · Visual, Pregnancy Hcg, Prescription Use · 51d
Cleared Oct 23, 1991
STAMBI-CK
K913349 · Intl. Immunoassay Laboratories, Inc.
JHW · U.v. Method, Cpk Isoenzymes · 89d
Cleared Oct 23, 1991
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)
K914462 · Serono-Baker Diagnostics, Inc.
JLS · Radioimmunoassay, Progesterone · 16d
Cleared Oct 21, 1991
LIPASE LINEARITY CONTROL
K913585 · Creative Laboratory Products, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 70d
Cleared Oct 21, 1991
ABBOTT QUICKSTART LD-1,#5A30
K914261 · Em Diagnostic Systems, Inc.
JGF · Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes · 28d
Cleared Oct 17, 1991
FIRST RESPONSE(R) ONE-STEP
K914304 · Armkel, LLC
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 22d
Cleared Oct 11, 1991
URINE/CSF MICROPROTEIN REAGENT
K913225 · Intersect Systems, Inc.
CEK · Biuret (colorimetric), Total Protein · 84d
Cleared Oct 11, 1991
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
K913307 · Em Diagnostic Systems, Inc.
CIG · Diazo Colorimetry, Bilirubin · 78d
Cleared Oct 11, 1991
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
K913927 · Instrumentation Laboratory CO
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 38d
Cleared Oct 11, 1991
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
K914202 · Baxter Diagnostics, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 22d
Cleared Oct 11, 1991
ABBOTT QUICKSTART LDH,#5A31
K914262 · Em Diagnostic Systems, Inc.
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 18d
Cleared Oct 11, 1991
TARGET(TM)-HOG
K914303 · V-Tech, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 16d

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All categories 11260 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 477 JJX Single (specified) Analyte Controls (assayed And Unassayed) 388 CGA Glucose Oxidase, Glucose 304 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 187 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