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
11255 Chemistry devices
5626–5650 of 11255
Cleared Jul 17, 1992
OLYMPUS URIC ACID REAGENT
K922756 · Olympus Corp.
KNK · Acid, Uric, Uricase (colorimetric) · 38d
Cleared Jul 16, 1992
OLYMPUS GLUCOSE REAGENT
K922232 · Olympus Corp.
CFR · Hexokinase, Glucose · 65d
Cleared Jul 16, 1992
OLYMPUS TOTAL PROTEIN REAGENT
K922361 · Olympus Corp.
CEK · Biuret (colorimetric), Total Protein · 58d
Cleared Jul 15, 1992
KING DIAGNOSTICS AST (GOT) REAGENT
K922108 · King Diagnostics, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 71d
Cleared Jul 14, 1992
BLOOD GAS/ISE LINEARITY CONTROL
K920285 · Phoenix Diagnostics, Inc.
JJS · Controls For Blood-gases, (assayed And Unassayed) · 174d
Cleared Jul 14, 1992
WAKO AUTOKIT MICRO TP
K920531 · Wako Chemicals USA, Inc.
CEK · Biuret (colorimetric), Total Protein · 160d
Cleared Jul 13, 1992
OLYMPUS CREATINE KINASE REAGENT
K922459 · Olympus Corp.
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 48d
Cleared Jul 10, 1992
DSL ACTIVE ALDOSTERONE (DSL 8600)
K921205 · Diagnostic Systems Laboratories, Inc.
CJM · Radioimmunoassay, Aldosterone · 120d
Cleared Jul 10, 1992
VACUTAINER BRAND LUER ADAPTER
K921520 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 101d
Cleared Jul 10, 1992
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
K922046 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 70d
Cleared Jul 10, 1992
KODAK EKTACHEM 250 ANALYER
K922072 · Eastman Kodak Company
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 67d
Cleared Jul 10, 1992
OLYMPUS CALCIUM REAGENT
K922233 · Olympus Corp.
CIC · Cresolphthalein Complexone, Calcium · 59d
Cleared Jul 10, 1992
OLYMPUS UREA NITROGEN (BUN) REAGENT
K922597 · Olympus Corp.
CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 38d
Cleared Jul 10, 1992
KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA
K922736 · Eastman Kodak Company
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 32d
Cleared Jul 09, 1992
SINGLE-STEP PREGNANCY, HCG TEST
K922290 · American Medical Products, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 55d
Cleared Jul 09, 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · Roche Diagnostic Systems, Inc.
KNK · Acid, Uric, Uricase (colorimetric) · 51d
Cleared Jul 07, 1992
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
K920636 · Baxter Diagnostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 146d
Cleared Jul 07, 1992
THYROXINE (T4) COATED TUBE RIA
K921935 · Monobind
CDX · Radioimmunoassay, Total Thyroxine · 74d
Cleared Jul 02, 1992
OLYMPUS TRIGLYCERIDE REAGENT
K922229 · Olympus Corp.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 51d
Cleared Jun 30, 1992
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
K921661 · Boehringer Mannheim Corp.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 84d
Cleared Jun 30, 1992
RNA MEDICAL'S EQUIL 55
K922357 · Bionostics, Inc.
JJS · Controls For Blood-gases, (assayed And Unassayed) · 42d
Cleared Jun 29, 1992
TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093
K921700 · Medix Biotech, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 82d
Cleared Jun 26, 1992
RNA MEDICAL TONOMETER
K922386 · Bionostics, Inc.
LCH · Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical · 37d
Cleared Jun 25, 1992
MILENIA FOLIC ACID
K921614 · Diagnostic Products Corp.
CGN · Acid, Folic, Radioimmunoassay · 80d
Cleared Jun 25, 1992
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER
K922220 · Olympus Corp.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 44d

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All categories 11255 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 474 JJX Single (specified) Analyte Controls (assayed And Unassayed) 388 CGA Glucose Oxidase, Glucose 303 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