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
11332 Chemistry devices
10601–10625 of 11332
Cleared May 15, 1979
CENTRIFICHEM INORGANIC PHOSPHORUS
K790662 · Union Carbide Corp.
CED · 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase · 39d
Cleared May 15, 1979
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
K790665 · Micromedic Systems
CDX · Radioimmunoassay, Total Thyroxine · 39d
Cleared May 15, 1979
LD-P REAGENT (LDH P-L REAGENT)
K790771 · Gilford Diagnostics
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 25d
Cleared May 07, 1979
CENTRIA SYSTEM
K790550 · Union Carbide Corp.
JJG · Analyzer, Chemistry, Centrifugal, For Clinical Use · 48d
Cleared May 07, 1979
CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC
K790556 · Calbiochem-Behring Corp.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 49d
Cleared May 07, 1979
RIA KIT, QUANTITATION OF PROSTATIC ACID
K790817 · New England Nuclear
JFH · Acid Phosphatase (prostatic), Tartrate Inhibited · 10d
Cleared May 03, 1979
H-D-EL
K790372 · General Diagnostics
LBR · Ldl & Vldl Precipitation, Hdl · 69d
Cleared May 03, 1979
T-3 UPTAKE (MAA) KIT
K790461 · Amersham Corp.
KHQ · Radioassay, Triiodothyronine Uptake · 59d
Cleared May 03, 1979
COULTER ACCU-ZYME II GOT REAGENT
K790483 · Coulter Electronics, Inc.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 55d
Cleared May 03, 1979
AMYLOCHROME STAT SEPARATOR, TEST
K790485 · Hoffmann-La Roche, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 52d
Cleared May 03, 1979
THE ABBOTT EXECUTIVE
K790543 · Abbott Laboratories
JQP · Calculator/data Processing Module, For Clinical Use · 42d
Cleared May 03, 1979
HEATING BLOCK, WAMPOLE 37 C
K790549 · Armkel, LLC
JRG · Block, Heating · 44d
Cleared May 01, 1979
DATA-ZYME CK CALORIMETRIC/UV PROCEDURE
K790343 · Data Medical Associates, Inc.
JHS · Differential Rate Kinetic Method, Cpk Or Isoenzymes · 69d
Cleared May 01, 1979
COULTER ACCU-ZYME II GPT REAGENT
K790522 · Coulter Electronics, Inc.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 53d
Cleared Apr 26, 1979
TY RIA KIT, AUTOMATED ASSAY SYSTEM
K790477 · E. R. Squibb & Sons, Inc.
CDX · Radioimmunoassay, Total Thyroxine · 48d
Cleared Apr 23, 1979
FLOZYME* URIC ACID REAGENT
K790486 · Worthington Diagnostic Systems
KNK · Acid, Uric, Uricase (colorimetric) · 42d
Cleared Apr 20, 1979
T3 UPTAKE KIT
K790417 · E. R. Squibb & Sons, Inc.
KHQ · Radioassay, Triiodothyronine Uptake · 51d
Cleared Apr 20, 1979
MULTISKAN (78-503-00)
K790422 · Flow Laboratories, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 51d
Cleared Apr 17, 1979
P.A.P. TEST KIT, RIA-ZYME
K790040 · Mallinckrodt Critical Care
JFH · Acid Phosphatase (prostatic), Tartrate Inhibited · 99d
Cleared Apr 04, 1979
PREGNANCY, SENSIDEX TUBE TEST
K782063 · Ortho Diagnostics, Inc.
JHJ · Agglutination Method, Human Chorionic Gonadotropin · 114d
Cleared Apr 04, 1979
SLIDE TEST FOR PREGNANCY, GRAVINDEX 90
K782166 · Ortho Diagnostics, Inc.
JHJ · Agglutination Method, Human Chorionic Gonadotropin · 96d
Cleared Apr 04, 1979
NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
K790248 · Boehringer Laboratories
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 55d
Cleared Apr 04, 1979
ANALYZER, CENTRIFUCHEM SYSTEM 400
K790278 · Union Carbide Corp.
JJG · Analyzer, Chemistry, Centrifugal, For Clinical Use · 54d
Cleared Apr 04, 1979
UNION CARBIDE CORP. COMPUTER INTERFACE
K790336 · Union Carbide Corp.
JQP · Calculator/data Processing Module, For Clinical Use · 42d
Cleared Apr 04, 1979
CPK-CS
K790357 · Hoffmann-La Roche, Inc.
JHT · Chromatographic Separation, Cpk Isoenzymes · 40d

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All categories 11332 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 312 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 188 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