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
11229 Chemistry devices
4026–4050 of 11229
Cleared Oct 06, 1997
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K973367 · Radiometer America, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 28d
Cleared Oct 01, 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
K972891 · Roche Diagnostic Systems, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 57d
Cleared Oct 01, 1997
REP SPE VIS-60/40 KIT
K973316 · Helena Laboratories
CEF · Electrophoretic, Protein Fractionation · 28d
Cleared Sep 29, 1997
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
K973451 · Medical Analysis Systems, Inc.
JJW · Urinalysis Controls (assayed And Unassayed) · 18d
Cleared Sep 25, 1997
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY
K972761 · Sealite Sciences, Inc.
CFL · Radioimmunoassay, Human Growth Hormone · 63d
Cleared Sep 25, 1997
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
K973109 · Synermed, Inc.
CIG · Diazo Colorimetry, Bilirubin · 37d
Cleared Sep 25, 1997
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS
K973469 · Consolidated Technologies, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 21d
Cleared Sep 25, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K973517 · Johnson & Johnson Clinical Diagnostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 8d
Cleared Sep 24, 1997
CHOLESTEROL RAPID LIQUID REAGENT
K972853 · Reagents Applications, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 89d
Cleared Sep 22, 1997
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972580 · Bayer Corp.
JMM · Column Chromatography & Color Development, Hydroxyproline · 74d
Cleared Sep 22, 1997
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
K972743 · Sigma Diagnostics, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 61d
Cleared Sep 17, 1997
GLUCOSITE TEST SYSTEM
K971145 · Gds Technology, LLC
CGA · Glucose Oxidase, Glucose · 173d
Cleared Sep 11, 1997
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666 · Hybritech, Inc.
CIN · Electrophoretic Separation, Alkaline Phosphatase Isoenzymes · 57d
Cleared Sep 09, 1997
CLINITEK MICROALBUMIN REAGENT STRIPS
K972706 · Bayer Corp.
CJG · Tetrabromo-m-cresolsulfonphthalein, Albumin · 50d
Cleared Sep 09, 1997
AVL OMNI ANALYZER
K972733 · Avl Scientific Corp.
CGA · Glucose Oxidase, Glucose · 50d
Cleared Sep 04, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
K973030 · Johnson & Johnson Clinical Diagnostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 21d
Cleared Sep 02, 1997
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
K971458 · Diagnostic Specialties
JIQ · Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) · 133d
Cleared Sep 02, 1997
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
K972720 · Monobind
CGJ · Radioimmunoassay, Follicle-stimulating Hormone · 43d
Cleared Aug 29, 1997
AIA-PACK TSH 3RD-GEN ASSAY
K972586 · Tosoh Medics, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 49d
Cleared Aug 29, 1997
PREGNACOL PREGNANCY TEST
K972606 · Immunostics Inc.,
JHJ · Agglutination Method, Human Chorionic Gonadotropin · 49d
Cleared Aug 29, 1997
QUICKVUE ONE-STEP HCG-URINE
K972742 · Quidel Corp.
JHI · Visual, Pregnancy Hcg, Prescription Use · 37d
Cleared Aug 29, 1997
CARDS Q.S. HCG-URINE
K972748 · Quidel Corp.
JHI · Visual, Pregnancy Hcg, Prescription Use · 37d
Cleared Aug 29, 1997
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
K972976 · More Diagnostics
JJT · Enzyme Controls (assayed And Unassayed) · 18d
Cleared Aug 28, 1997
AG CHEMISTRY ANALYZER SYSTEM
K972409 · Landmark Scientific, Inc.
JJG · Analyzer, Chemistry, Centrifugal, For Clinical Use · 63d
Cleared Aug 28, 1997
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
K972868 · Bionostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 24d

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All categories 11229 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 466 JJX Single (specified) Analyte Controls (assayed And Unassayed) 385 CGA Glucose Oxidase, Glucose 301 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 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