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.

13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3205 Chemistry devices
1626–1650 of 3205
Cleared Sep 23, 1992
DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR
K922699 · E.I. Dupont DE Nemours & Co., Inc.
JIS · Calibrator, Primary · 111d
Cleared Sep 23, 1992
TITAN GEL ALKALINE PHOSPHATASE (HR)
K921578 · Helena Laboratories
CIN · Electrophoretic Separation, Alkaline Phosphatase Isoenzymes · 174d
Cleared Sep 22, 1992
SYSTEMATE URICACID TEST, TECHNICON RA 1000
K923765 · Em Diagnostic Systems, Inc.
CDO · Acid, Uric, Uricase (u.v.) · 56d
Cleared Sep 22, 1992
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000
K923764 · Em Diagnostic Systems, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 56d
Cleared Sep 18, 1992
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · Syva Co.
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 155d
Cleared Sep 17, 1992
IL TEST ALT, PN 35311
K923623 · Instrumentation Laboratory CO
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 58d
Cleared Sep 09, 1992
AMYLASE TEST
K923677 · Em Diagnostic Systems, Inc.
JFJ · Catalytic Methods, Amylase · 49d
Cleared Sep 09, 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
K923267 · Em Diagnostic Systems, Inc.
CEK · Biuret (colorimetric), Total Protein · 69d
Cleared Sep 09, 1992
SYSTEMATE CREATININE TEST
K923203 · Em Diagnostic Systems, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 76d
Cleared Sep 09, 1992
TOTAL BILIRUBIN CATALOG NO. 65407
K923083 · Em Diagnostic Systems, Inc.
CIG · Diazo Colorimetry, Bilirubin · 76d
Cleared Sep 09, 1992
SYSTEMATE CALCIUM TEST TECHNICON RA 1000
K922953 · Em Diagnostic Systems, Inc.
CIL · Cresol Red Colorimetry, Carbon-dioxide · 83d
Cleared Sep 09, 1992
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
K922857 · Em Diagnostic Systems, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 86d
Cleared Sep 09, 1992
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
K922856 · Em Diagnostic Systems, Inc.
CIG · Diazo Colorimetry, Bilirubin · 86d
Cleared Sep 09, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD
K922701 · E.I. Dupont DE Nemours & Co., Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 97d
Cleared Sep 09, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR
K922698 · E.I. Dupont DE Nemours & Co., Inc.
JIS · Calibrator, Primary · 97d
Cleared Sep 02, 1992
AMERLITE PROLACTIN-30 ASSAY
K922170 · Eastman Kodak Company
CFT · Radioimmunoassay, Prolactin (lactogen) · 117d
Cleared Sep 02, 1992
COTUBE PTH IRMA
K921949 · Bio-Rad
CEW · Radioimmunoassay, Parathyroid Hormone · 128d
Cleared Aug 24, 1992
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
K922913 · Syva Co.
LBZ · Enzyme Immunoassay, Quinidine · 68d
Cleared Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
K922700 · E.I. Dupont DE Nemours & Co., Inc.
JHY · Colorimetric Method, Cpk Or Isoenzymes · 77d
Cleared Aug 19, 1992
ARRAY(R) 360
K922273 · Beckman Instruments, Inc.
JQX · Nephelometer, For Clinical Use · 97d
Cleared Aug 18, 1992
REP SPE PLUS (PONCEAU S) SYSTEM
K922053 · Helena Laboratories
CEF · Electrophoretic, Protein Fractionation · 106d
Cleared Aug 12, 1992
DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO
K922696 · E.I. Dupont DE Nemours & Co., Inc.
JIS · Calibrator, Primary · 69d
Cleared Aug 10, 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K923165 · Eastman Kodak Company
JJY · Multi-analyte Controls, All Kinds (assayed) · 42d
Cleared Aug 10, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · E.I. Dupont DE Nemours & Co., Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 67d
Cleared Jul 28, 1992
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K921180 · Roche Diagnostic Systems, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 140d

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All categories 3205 JJY Multi-analyte Controls, All Kinds (assayed) 124 NBW System, Test, Blood Glucose, Over The Counter 97 JJX Single (specified) Analyte Controls (assayed And Unassayed) 94 JIX Calibrator, Multi-analyte Mixture 73 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 72 CIG Diazo Colorimetry, Bilirubin 65 JIT Calibrator, Secondary 62 CGA Glucose Oxidase, Glucose 56 JLW Radioimmunoassay, Thyroid-stimulating Hormone 53 CHH Enzymatic Esterase--oxidase, Cholesterol 52 MMI Immunoassay Method, Troponin Subunit 46 JHI Visual, Pregnancy Hcg, Prescription Use 45 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 44 JIS Calibrator, Primary 41 CGX Alkaline Picrate, Colorimetry, Creatinine 38