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.

13249
Total
13217
Cleared
177d
Avg (2y)
1976
Since
11342 Chemistry devices
11201–11225 of 11342
Cleared Mar 21, 1977
CLINILAB AUTOMATED URINALYSIS SYSTEM
K761306 · Miles Laboratories, Inc.
KQO · Automated Urinalysis System · 89d
Cleared Mar 21, 1977
MEGA-DIASTIX
K761310 · Miles Laboratories, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 88d
Cleared Mar 21, 1977
VITAMIN B12 RADIOASSAY
K761321 · Kallestad Laboratories, Inc.
CDD · Radioassay, Vitamin B12 · 84d
Cleared Mar 21, 1977
MT II SYSTEM - SERUM ALBUMIN
K761329 · Technicon Instruments Corp.
CIX · Bromcresol Green Dye-binding, Albumin · 84d
Cleared Mar 16, 1977
CHEMSTRIP G
K770271 · Boehringer Mannheim Corp.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 30d
Cleared Mar 10, 1977
SPECTROPHOTOMETERS, INFRARED MODELS X99
K770278 · The Perkin-Elmer Corp.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 24d
Cleared Mar 10, 1977
SPECTROPHOTOMETER, MODEL 597 IR
K770288 · The Perkin-Elmer Corp.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 24d
Cleared Mar 01, 1977
AUTO-ENZYMATIC GLUCOSE
K770229 · Harleco
CFR · Hexokinase, Glucose · 22d
Cleared Mar 01, 1977
URIC ACID TEST, BMC AUTOFLO
K770272 · Boehringer Mannheim Corp.
KNK · Acid, Uric, Uricase (colorimetric) · 15d
Cleared Mar 01, 1977
TEST, AMMONIA, BMC REAGENTSET
K770273 · Boehringer Mannheim Corp.
JIF · Enzymatic Method, Ammonia · 15d
Cleared Feb 25, 1977
CHOLESTEROL TEST
K770265 · Sclavo, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 14d
Cleared Feb 24, 1977
TRI-CON TRIGLYCERIDGE REAGENTS
K761283 · Dade, Baxter Travenol Diagnostics, Inc.
JGY · Colorimetric Method, Triglycerides · 66d
Cleared Feb 24, 1977
COMPU-PET 300
K761290 · Nuclear Medical Laboratories, Inc.
JQW · Station, Pipetting And Diluting, For Clinical Use · 65d
Cleared Feb 23, 1977
GO/HPO-GLUCOSE REAGENT (TRINDER)
K770200 · Beckman Instruments, Inc.
CGA · Glucose Oxidase, Glucose · 23d
Cleared Feb 23, 1977
GLUCOSE (HEXOKINASE) DELTA TEST ASSAY
K770262 · Bd Becton Dickinson Vacutainer Systems Preanalytic
CFR · Hexokinase, Glucose · 12d
Cleared Feb 23, 1977
LDH-L TEST
K770267 · Sclavo, Inc.
CFJ · Nad Reduction/nadh Oxidation, Lactate Dehydrogenase · 12d
Cleared Feb 22, 1977
REAGENT SYSTEM
K770242 · American Monitor Corp.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 15d
Cleared Feb 14, 1977
AUTO CREATININE REAGENT (GILFORD 3400-E)
K761280 · Harleco
CGX · Alkaline Picrate, Colorimetry, Creatinine · 56d
Cleared Feb 11, 1977
REFLOMAT/REFLOTEST SYSTEM
K761148 · Boehringer Mannheim Corp.
CGA · Glucose Oxidase, Glucose · 77d
Cleared Feb 11, 1977
AUTO CREATININE REAGENT (ABBOTT SYSTEM)
K761279 · Harleco
CGX · Alkaline Picrate, Colorimetry, Creatinine · 53d
Cleared Feb 11, 1977
SMA REFERENCE SERUM 3
K770142 · Technicon Instruments Corp.
JIX · Calibrator, Multi-analyte Mixture · 18d
Cleared Feb 09, 1977
DATA-TOPE T3 UPTAKE PROCEDURE
K761281 · Dade, Baxter Travenol Diagnostics, Inc.
KHQ · Radioassay, Triiodothyronine Uptake · 51d
Cleared Feb 01, 1977
SMA MICROLYZER
K761342 · Technicon Instruments Corp.
JJC · Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use · 35d
Cleared Jan 31, 1977
MANUEL BILIRUBIN REAGENT SET
K770121 · Harleco
CIG · Diazo Colorimetry, Bilirubin · 10d
Cleared Jan 31, 1977
CENTRIFICHEM CHOLES. CALIB. STD. SET
K770126 · Union Carbide Corp.
JIT · Calibrator, Secondary · 10d

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All categories 11342 NBW System, Test, Blood Glucose, Over The Counter 497 JJY Multi-analyte Controls, All Kinds (assayed) 495 JJX Single (specified) Analyte Controls (assayed And Unassayed) 389 CGA Glucose Oxidase, Glucose 313 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 249 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 200 CHH Enzymatic Esterase--oxidase, Cholesterol 190 JLW Radioimmunoassay, Thyroid-stimulating Hormone 189 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