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
11231 Chemistry devices
4101–4125 of 11231
Cleared Jun 20, 1997
CHOLESTEROL REAGENT
K971072 · Derma Media Lab., Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 88d
Cleared Jun 20, 1997
TRIGLYCERIDES, TG, OR TRIG
K971324 · Carolina Liquid Chemistries Corp.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 71d
Cleared Jun 18, 1997
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
K971573 · Genzyme Corp.
LBR · Ldl & Vldl Precipitation, Hdl · 49d
Cleared Jun 18, 1997
OPUS PROGESTERONE
K971725 · Behring Diagnostics, Inc.
JLS · Radioimmunoassay, Progesterone · 40d
Cleared Jun 18, 1997
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3
K972080 · Consolidated Technologies, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 15d
Cleared Jun 17, 1997
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
K971449 · Becton Dickinson Vacutainer Systems
GIM · Tubes, Vacuum Sample, With Anticoagulant · 57d
Cleared Jun 17, 1997
CREA OR CREATININE
K971908 · Carolina Liquid Chemistries Corp.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 25d
Cleared Jun 17, 1997
BUN
K971967 · Carolina Liquid Chemistries Corp.
CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 20d
Cleared Jun 16, 1997
TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER
K971111 · Tri-Tech, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 82d
Cleared Jun 16, 1997
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
K971162 · Genzyme Corp.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 77d
Cleared Jun 16, 1997
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K971190 · Genzyme Corp.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 77d
Cleared Jun 16, 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · Bayer Corp.
CFR · Hexokinase, Glucose · 70d
Cleared Jun 16, 1997
SPECIALITY URINE 1,2
K971405 · Chiron Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 61d
Cleared Jun 16, 1997
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
K971467 · Carolina Liquid Chemistries Corp.
CFR · Hexokinase, Glucose · 55d
Cleared Jun 16, 1997
TOTAL THROXINE MICROPLATE EIA(225-300)
K971709 · Monobind
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 39d
Cleared Jun 16, 1997
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
K971779 · Monobind
CDP · Radioimmunoassay, Total Triiodothyronine · 33d
Cleared Jun 16, 1997
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
K971823 · Diagnostic Systems Laboratories, Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 31d
Cleared Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · Roche Diagnostic Systems, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 24d
Cleared Jun 16, 1997
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
K971952 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 19d
Cleared Jun 16, 1997
ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
K972004 · Alko Diagnostic Corp.
CGZ · Electrode, Ion-specific, Chloride · 17d
Cleared Jun 13, 1997
LXN FRUCTOSAMINE TEST SYSTEM
K962597 · Lxn Corp.
LCP · Assay, Glycosylated Hemoglobin · 346d
Cleared Jun 11, 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505 · Beckman Instruments, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 47d
Cleared Jun 11, 1997
OLYMPUS CK-MB REAGENT
K971817 · Olympus America, Inc.
JLB · Atp And Creatine Kinase (enzymatic), Creatine · 26d
Cleared Jun 11, 1997
ACCUTEST HCG-URINE
K971886 · Unotech Diagnostics, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 20d
Cleared Jun 11, 1997
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
K971954 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 14d

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All categories 11231 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 467 JJX Single (specified) Analyte Controls (assayed And Unassayed) 385 CGA Glucose Oxidase, Glucose 301 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 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