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
11326 Chemistry devices
10551–10575 of 11326
Cleared Jul 24, 1979
BECKMAN ELECTROPHORESIS OVEN/INCUBATOR
K791077 · Beckman Instruments, Inc.
JRJ · Unit, Drying · 42d
Cleared Jul 24, 1979
PLUS CHEM S.C.E. REAGENT
K791080 · Smithkline Diagnostics, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 42d
Cleared Jul 17, 1979
HUMAN CHORIONIC GONADOTROPHIN STANDARDS
K790863 · Pcl-Ria, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 71d
Cleared Jul 17, 1979
RABBIT ANTISERUM TO HUMAN CHORIONIC
K790864 · Pcl-Ria, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 71d
Cleared Jul 17, 1979
LABELED HUMAN CHORIONIC GONADOTROPHIN
K790876 · Pcl-Ria, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 71d
Cleared Jul 17, 1979
P.A.P. RIA CONTROL SERUM PACK
K790985 · Mallinckrodt Critical Care
JJT · Enzyme Controls (assayed And Unassayed) · 53d
Cleared Jul 17, 1979
NORMAL PROTEIN ELECTROPHORESIS CONTROL
K791029 · Beckman Instruments, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 43d
Cleared Jul 17, 1979
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL
K791031 · Beckman Instruments, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 43d
Cleared Jul 17, 1979
GAMMADAB (125 1) FOLATE RADIOASSAY KIT
K791079 · Clinical Assays, Inc.
CGN · Acid, Folic, Radioimmunoassay · 35d
Cleared Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF LDH-
K791081 · Smithkline Diagnostics, Inc.
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 35d
Cleared Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF AST
K791082 · Smithkline Diagnostics, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 35d
Cleared Jul 17, 1979
SPIN CHEM, DETERMINATION OF ALT (GPT)
K791083 · Smithkline Diagnostics, Inc.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF ALT (GPT)
K791084 · Smithkline Diagnostics, Inc.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF LD (LDH-P)
K791085 · Smithkline Diagnostics, Inc.
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 35d
Cleared Jul 17, 1979
CARY 210 SERIES, SPECTROPHOTOMETER
K791102 · Varian Assoc., Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 34d
Cleared Jun 28, 1979
COULTER ACCU-ZYME IIY-GT REAGENT KIT
K790812 · Coulter Electronics, Inc.
JPZ · Colorimetric Method, Gamma-glutamyl Transpeptidase · 63d
Cleared Jun 28, 1979
MULTECON BLOOD GAS CONTROL
K790813 · Ortho Diagnostics, Inc.
JJS · Controls For Blood-gases, (assayed And Unassayed) · 62d
Cleared Jun 28, 1979
UV URIC ACID DETERMINATION
K790834 · The Dow Chemical Co.
CDO · Acid, Uric, Uricase (u.v.) · 59d
Cleared Jun 28, 1979
THYROID CONTROL SERA CODE QAS.101
K790840 · Amersham Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 57d
Cleared Jun 28, 1979
LANCER HDL SEPARATION KIT
K790865 · Sherwood Medical Co.
LBR · Ldl & Vldl Precipitation, Hdl · 52d
Cleared Jun 28, 1979
AUTO ENZYMATIC CHOLESTEROL
K790947 · Macomb Chemical Co.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 41d
Cleared Jun 28, 1979
REAGENT STRIPS FOR URINALYSIS
K790965 · Miles Laboratories, Inc.
CDM · Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) · 37d
Cleared Jun 27, 1979
AUTOPAK CORTISOL TEST DELIVERY SYSTEM
K790906 · Micromedic Systems
CGR · Radioimmunoassay, Cortisol · 47d
Cleared Jun 27, 1979
AUTOPAK TEST DELIVERY SYSTEM
K790907 · Micromedic Systems
CDX · Radioimmunoassay, Total Thyroxine · 47d
Cleared Jun 27, 1979
RIA, TEST SET CENTRIA T3
K790908 · Ventrex Laboratories, Inc.
CDP · Radioimmunoassay, Total Triiodothyronine · 44d

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All categories 11326 NBW System, Test, Blood Glucose, Over The Counter 497 JJY Multi-analyte Controls, All Kinds (assayed) 493 JJX Single (specified) Analyte Controls (assayed And Unassayed) 389 CGA Glucose Oxidase, Glucose 311 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 249 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 200 JLW Radioimmunoassay, Thyroid-stimulating Hormone 189 CHH Enzymatic Esterase--oxidase, Cholesterol 187 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 177 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 158 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143