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
5876–5900 of 11260
Cleared Aug 12, 1991
MILENIA TOTAL T4, CATALOG: MKT41,5
K912541 · Diagnostic Products Corp.
CDX · Radioimmunoassay, Total Thyroxine · 63d
Cleared Aug 12, 1991
MAGIC LITE TSH (HS) IMMUNOASSAY
K912583 · Ciba Corning Diagnostics Corp.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 61d
Cleared Aug 12, 1991
BIOTROL UIBC REAGENT
K912795 · Biotrol, USA, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 48d
Cleared Aug 12, 1991
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
K912809 · Em Diagnostic Systems, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 48d
Cleared Aug 12, 1991
REFLOTRON CREATININE TEST TABS
K913105 · Boehringer Mannheim Corp.
JFY · Enzymatic Method, Creatinine · 31d
Cleared Aug 12, 1991
ROCHE REAGENT FOR AMMONIA
K913124 · Roche Diagnostic Systems, Inc.
JIF · Enzymatic Method, Ammonia · 28d
Cleared Aug 12, 1991
ROCHE REAGENT FOR ETHANOL
K913125 · Roche Diagnostic Systems, Inc.
DIC · Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method · 28d
Cleared Jul 30, 1991
CHOLESTECH LIPID MONITORING SYS.
K912136 · Cholestech Corp.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 77d
Cleared Jul 30, 1991
REP ALP-15, 8, & 4 KITS
K912603 · Helena Laboratories
CIN · Electrophoretic Separation, Alkaline Phosphatase Isoenzymes · 50d
Cleared Jul 30, 1991
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
K912725 · Creative Laboratory Products, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 40d
Cleared Jul 30, 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · Em Diagnostic Systems, Inc.
CFR · Hexokinase, Glucose · 35d
Cleared Jul 30, 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · Em Diagnostic Systems, Inc.
CEK · Biuret (colorimetric), Total Protein · 35d
Cleared Jul 30, 1991
SYNERMED SERUM IRON-600 REAGENT KIT
K912912 · Synermed, Inc.
CFM · Bathophenanthroline, Colorimetry, Iron (non-heme) · 27d
Cleared Jul 30, 1991
MILENIA ESTRADIOL
K912917 · Diagnostic Products Corp.
CHP · Radioimmunoassay, Estradiol · 27d
Cleared Jul 26, 1991
MAGNESIUM ASSAY KIT, CAT.# 100-12
K912825 · Diagnostic Chemicals, Ltd. (Usa)
JGJ · Photometric Method, Magnesium · 30d
Cleared Jul 26, 1991
MICROTRAK MANAGER
K912959 · Syva Co.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 18d
Cleared Jul 26, 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · Em Diagnostic Systems, Inc.
JQB · Kinetic Method, Gamma-glutamyl Transpeptidase · 17d
Cleared Jul 25, 1991
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
K912318 · Serono-Baker Diagnostics, Inc.
CHP · Radioimmunoassay, Estradiol · 62d
Cleared Jul 24, 1991
QUIKPAC-II ONE STEP PREGNANCY HOME TEST
K912316 · Syntron Bioresearch, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 61d
Cleared Jul 22, 1991
AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
K912733 · Amersham Corp.
CIG · Diazo Colorimetry, Bilirubin · 32d
Cleared Jul 19, 1991
IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
K911826 · Disease Detection International, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 86d
Cleared Jul 19, 1991
ROCHE REAGENT FOR C02
K911838 · Roche Diagnostic Systems, Inc.
CHS · Coulometric Method, Carbon-dioxide · 85d
Cleared Jul 19, 1991
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
K912024 · Wako Chemicals USA, Inc.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 77d
Cleared Jul 19, 1991
TARGET MICROALBUMINURIA TEST
K912246 · Texas Immunology, Inc.
JIR · Indicator Method, Protein Or Albumin (urinary, Non-quant.) · 59d
Cleared Jul 18, 1991
MAGNETIC HDL CHOLESTEROL TEST
K911906 · Reference Diagnostics, Inc.
LBR · Ldl & Vldl Precipitation, Hdl · 79d

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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