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
11287 Chemistry devices
8251–8275 of 11287
Cleared Jun 25, 1985
CK/LD ISOENZYMES CONTROLS(HUMAN)
K851520 · Seragen Diagnostics, Inc.
JJT · Enzyme Controls (assayed And Unassayed) · 71d
Cleared Jun 25, 1985
TANDEM E PAP
K851950 · Hybritech, Inc.
JFH · Acid Phosphatase (prostatic), Tartrate Inhibited · 53d
Cleared Jun 25, 1985
INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU
K851990 · Alpkem Corp.
JIX · Calibrator, Multi-analyte Mixture · 49d
Cleared Jun 25, 1985
CA BUFFER CA DYE
K852002 · Alpkem Corp.
CIC · Cresolphthalein Complexone, Calcium · 49d
Cleared Jun 25, 1985
MG REAGENT
K852005 · Alpkem Corp.
JGJ · Photometric Method, Magnesium · 49d
Cleared Jun 25, 1985
PREGNANCY CARD TEST
K852066 · Em Diagnostic Systems, Inc.
JHJ · Agglutination Method, Human Chorionic Gonadotropin · 46d
Cleared Jun 25, 1985
ASSIST CLINICAL CHEMISTRY ANALYZER
K852262 · Cooper Biomedical, Inc.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 32d
Cleared Jun 19, 1985
WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
K844637 · Dow Corning Corp. Healthcare Industries Materials
LTC · Hyaline Membrane Disease Assay · 203d
Cleared Jun 14, 1985
CORNING CERTAIN -ISE
K851939 · Corning Medical & Scientific
JIX · Calibrator, Multi-analyte Mixture · 42d
Cleared Jun 13, 1985
MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA
K851329 · Corning Medical & Scientific
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 70d
Cleared Jun 10, 1985
G-GT REAGENT
K851999 · Alpkem Corp.
JQB · Kinetic Method, Gamma-glutamyl Transpeptidase · 34d
Cleared Jun 10, 1985
AMY REAGENT
K852001 · Alpkem Corp.
JFJ · Catalytic Methods, Amylase · 34d
Cleared Jun 10, 1985
TP BIURET REAGENT
K852006 · Alpkem Corp.
CEK · Biuret (colorimetric), Total Protein · 34d
Cleared Jun 10, 1985
GLUCOSE(TRINDER) REAGENT
K852130 · Sigma Diagnostics, Inc.
CGA · Glucose Oxidase, Glucose · 25d
Cleared Jun 10, 1985
BUN(ENDPOINT) REAGENT
K852131 · Sigma Diagnostics, Inc.
CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 25d
Cleared Jun 06, 1985
SOMATOMEDIN C BY RADIOIMMUNOASSAY
K850892 · Immuno Nuclear Corp.
CFL · Radioimmunoassay, Human Growth Hormone · 94d
Cleared Jun 03, 1985
AST ASPARTATE AMINOTRANSFERASE REAGENT
K851994 · Alpkem Corp.
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 27d
Cleared May 31, 1985
DELFIA HTSH KIT
K851120 · Lkb Instruments, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 73d
Cleared May 31, 1985
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY
K851942 · Coulter Electronics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 28d
Cleared May 31, 1985
ENDAB TSH
K851980 · Immunotech Corp.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 24d
Cleared May 31, 1985
LD-L REAGENT
K851996 · Alpkem Corp.
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 24d
Cleared May 31, 1985
IP ACID REAGENT IP MOLY BDATE REAGENT
K852003 · Alpkem Corp.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 24d
Cleared May 31, 1985
SC-360 SPECTROPHOTOMETER
K852047 · Pharmacia, Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 22d
Cleared May 31, 1985
DIRECT BILIRUBEN CALIBRATIONS
K852067 · Data Medical Associates, Inc.
JIT · Calibrator, Secondary · 21d
Cleared May 31, 1985
TOTAL BILIRUBIN STANDARDS
K852068 · Data Medical Associates, Inc.
JIS · Calibrator, Primary · 21d

Looking for a specific chemistry device? Search by device name, K-number or manufacturer.

Search all Chemistry 510(k) devices

Filter by Product Code

All categories 11287 JJY Multi-analyte Controls, All Kinds (assayed) 492 NBW System, Test, Blood Glucose, Over The Counter 488 JJX Single (specified) Analyte Controls (assayed And Unassayed) 388 CGA Glucose Oxidase, Glucose 306 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 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 158 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143