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
11231 Chemistry devices
4076–4100 of 11231
Cleared Jul 23, 1997
AMMONIA/IRON STANDARD KIT
K972333 · Verichem Laboratories, Inc.
JIX · Calibrator, Multi-analyte Mixture · 30d
Cleared Jul 22, 1997
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754 · Pointe Scientific, Inc.,
CFR · Hexokinase, Glucose · 71d
Cleared Jul 22, 1997
PERSONALLAB AUTOMATED MICROPLATE ANALYZER
K971761 · Biochem Immunosystems (U.S.), Inc.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 71d
Cleared Jul 22, 1997
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
K972041 · Sigma Diagnostics, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 50d
Cleared Jul 20, 1997
BUN (LIQUID) REAGENT SET
K972671 · Pointe Scientific, Inc.,
CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 4d
Cleared Jul 17, 1997
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
K971418 · Chiron Diagnostics Corp.
MOI · System, Test, Immunological, Antigen, Tumor · 92d
Cleared Jul 17, 1997
CREATINE KINASE (CK)
K972155 · Stanbio Laboratory
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 42d
Cleared Jul 17, 1997
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K972297 · Trace America, Inc.
JFJ · Catalytic Methods, Amylase · 28d
Cleared Jul 14, 1997
ACS DIGITOXIN
K970546 · Chiron Diagnostics Corp.
LFM · Enzyme Immunoassay, Digitoxin · 152d
Cleared Jul 14, 1997
CREATINE KINASE-MB REAGENT SET
K971566 · Horizon Diagnostics, Inc.
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 76d
Cleared Jul 07, 1997
PRECINORM TDM CONTROLS
K971060 · Boehringer Mannheim Corp.
DIF · Drug Mixture Control Materials · 105d
Cleared Jul 07, 1997
DADE TRU-LIQUID BILIRUBIN CONTROL
K972287 · Dade Intl., Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 18d
Cleared Jun 30, 1997
MASTERCAP AM 5.0/MASTERCAP RM 5.0
K970420 · Pharmacia, Inc.
JQW · Station, Pipetting And Diluting, For Clinical Use · 147d
Cleared Jun 27, 1997
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K971103 · Tosoh Medics, Inc.
KHO · Fluorometer, For Clinical Use · 93d
Cleared Jun 27, 1997
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971716 · Bayer Corp.
LAR · Enzyme Immunoassay, Procainamide · 49d
Cleared Jun 26, 1997
SYNERMED IR 200 CHEMISTRY ANALYZER
K971491 · Synermed, Inc.
JJF · Analyzer, Chemistry, Micro, For Clinical Use · 63d
Cleared Jun 26, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS
K972070 · Nichols Institute Diagnostics
JJY · Multi-analyte Controls, All Kinds (assayed) · 23d
Cleared Jun 24, 1997
THYROTROPIN(TSH) ELISA
K971780 · Monobind
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 41d
Cleared Jun 24, 1997
CALCIUM REAGENT
K971907 · Carolina Liquid Chemistries Corp.
CIC · Cresolphthalein Complexone, Calcium · 32d
Cleared Jun 24, 1997
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
K971921 · Monobind
CFT · Radioimmunoassay, Prolactin (lactogen) · 32d
Cleared Jun 24, 1997
TOTAL BILIRUBIN REAGENT
K972073 · Carolina Liquid Chemistries Corp.
CIG · Diazo Colorimetry, Bilirubin · 21d
Cleared Jun 24, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
K972133 · Johnson & Johnson Clinical Diagnostics, Inc.
JLS · Radioimmunoassay, Progesterone · 18d
Cleared Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
K972214 · Roche Diagnostic Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 12d
Cleared Jun 24, 1997
ABBOTT AXSYM FOLATE
K972232 · Abbott Laboratories
CGN · Acid, Folic, Radioimmunoassay · 8d
Cleared Jun 20, 1997
ELECT II BLOOD GLUCOSE MONITORING SYSTEM
K970707 · Selfcare, Inc.
CGA · Glucose Oxidase, Glucose · 114d

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All categories 11231 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 467 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