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
11297 Chemistry devices
9076–9100 of 11297
Cleared Jul 29, 1983
LKB 2161 MIDISPIN R CENTRIFUGE
K831948 · Lkb Instruments, Inc.
JQC · Centrifuges (micro, Ultra, Refrigerated) For Clinical Use · 43d
Cleared Jul 28, 1983
PRO QUANTUM
K831249 · Abbott Laboratories
JQW · Station, Pipetting And Diluting, For Clinical Use · 101d
Cleared Jul 28, 1983
MODEL 947 VIDEO BLOOD GAS SYS
K831379 · Avl Scientific Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 91d
Cleared Jul 28, 1983
MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC
K831866 · Varian Assoc., Inc.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 48d
Cleared Jul 28, 1983
SICKLE-HEME A/S CONTROLS & A/A CONTROL
K831871 · Anco Medical Reagents & Assoc.
GHM · Test, Sickle Cell · 45d
Cleared Jul 26, 1983
HEATING BLOCK MICROELISA SYSTEM
K831642 · Organon Teknika Corp.
LIB · Device, General Purpose, Microbiology, Diagnostic · 64d
Cleared Jul 26, 1983
STRIPREADER MICROELISA SYSTEM
K831643 · Organon Teknika Corp.
LIB · Device, General Purpose, Microbiology, Diagnostic · 64d
Cleared Jul 26, 1983
MICROELISA COMP
K831658 · Organon Teknika Corp.
LIB · Device, General Purpose, Microbiology, Diagnostic · 64d
Cleared Jul 22, 1983
TRIGLYCERIDES REAGENT SET
K831858 · Stanbio Laboratory
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 42d
Cleared Jul 22, 1983
CHOLESTEROL-ENZYMATIC REAGENT SET
K831863 · Stanbio Laboratory
CHH · Enzymatic Esterase--oxidase, Cholesterol · 42d
Cleared Jul 22, 1983
URIC-ACID TEST ENZYMATIC COLORIMETRIC
K831864 · Stanbio Laboratory
KNK · Acid, Uric, Uricase (colorimetric) · 42d
Cleared Jul 19, 1983
GLUCOSE REAGENT B6360-11
K831634 · American Scientific Products
CGA · Glucose Oxidase, Glucose · 60d
Cleared Jul 19, 1983
RENAK
K831694 · Hoffmann-La Roche, Inc.
CIB · Radioimmunoassay, Angiotensin I And Renin · 56d
Cleared Jul 19, 1983
MULTICHEM ENZYMATIC CHOLESTEROL SYS
K831700 · Simmler, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 56d
Cleared Jul 19, 1983
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI
K831958 · Kent Laboratories, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 32d
Cleared Jul 19, 1983
RADIAL IMMUNO-TEST FOR HUMAN FACTOR B
K831959 · Kent Laboratories, Inc.
JZH · Factor B, Antigen, Antiserum, Control · 32d
Cleared Jul 19, 1983
TEST FOR HUMAN ALPHA ONE ACID GLYCO-
K831960 · Kent Laboratories, Inc.
LKL · Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control · 32d
Cleared Jul 19, 1983
ASTRA SYSTEMS ENZYME MODULE LD-P
K832048 · Beckman Instruments, Inc.
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 25d
Cleared Jul 18, 1983
MSI-NAK-50 TEST KIT
K831300 · Medical Specialties, Inc.
JGM · Flame Photometry, Potassium · 88d
Cleared Jul 18, 1983
SPINAL FLUID TOTAL PROTEIN CONTROL
K831527 · Quantimetrix Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 67d
Cleared Jul 18, 1983
WAKO R-GTP C-TEST
K831639 · Wako Chemicals USA, Inc.
JPZ · Colorimetric Method, Gamma-glutamyl Transpeptidase · 56d
Cleared Jul 18, 1983
MONOJET SPS BLOOD COLLECTION TUBE
K831719 · Sherwood Medical Co.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 48d
Cleared Jul 18, 1983
QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
K831742 · Bio-Rad
CGJ · Radioimmunoassay, Follicle-stimulating Hormone · 48d
Cleared Jul 18, 1983
GILCHEM TOTAL BILIRUBIN REAGENT
K831843 · Gilford Diagnostics
CIG · Diazo Colorimetry, Bilirubin · 40d
Cleared Jul 18, 1983
DIRECT BILIRUBIN REAGENT
K831844 · Gilford Diagnostics
CIG · Diazo Colorimetry, Bilirubin · 40d

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All categories 11297 JJY Multi-analyte Controls, All Kinds (assayed) 492 NBW System, Test, Blood Glucose, Over The Counter 491 JJX Single (specified) Analyte Controls (assayed And Unassayed) 388 CGA Glucose Oxidase, Glucose 307 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 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