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

11221 Chemistry devices

3401–3425 of 11221

Cleared Oct 05, 1999

ALCYON 300I (WITH ISE MODULE) ANALYZER

K993083 · Abbott Laboratories

CEM · Electrode, Ion Specific, Potassium · 20d

Cleared Oct 04, 1999

GENZYME DIRECT AMYLASE VERIFIER

K993132 · Genzyme Corp.

JIT · Calibrator, Secondary · 14d

Cleared Oct 04, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK

K993068 · Ortho-Clinical Diagnostics

JHX · Fluorometric Method, Cpk Or Isoenzymes · 21d

Cleared Oct 04, 1999

CARDIOQUANT TROPONIN I TEST

K992127 · Spectral Diagnostics, Inc.

MMI · Immunoassay Method, Troponin Subunit · 103d

Cleared Sep 30, 1999

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC

K990992 · Roche Diagnostics Corp.

LCP · Assay, Glycosylated Hemoglobin · 190d

Cleared Sep 28, 1999

SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5

K992801 · Sigma Diagnostics, Inc.

CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 40d

Cleared Sep 28, 1999

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

K992800 · Sigma Diagnostics, Inc.

CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 40d

Cleared Sep 28, 1999

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P

K992798 · Sigma Diagnostics, Inc.

CDO · Acid, Uric, Uricase (u.v.) · 40d

Cleared Sep 28, 1999

ELECSYS PARATHYROID HORMONE TEST SYSTEM

K992680 · Roche Diagnostics Corp.

CEW · Radioimmunoassay, Parathyroid Hormone · 49d

Cleared Sep 24, 1999

PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM

K992988 · Home Diagnostics, Inc.

CGA · Glucose Oxidase, Glucose · 21d

Cleared Sep 24, 1999

ELECSYS ESTRADIOL CALSET II

K992981 · Roche Diagnostics Corp.

JIT · Calibrator, Secondary · 21d

Cleared Sep 24, 1999

HEMOCHEK URINE COLLECTION KIT

K991800 · Osborn Group, Inc.

JIQ · Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) · 121d

Cleared Sep 23, 1999

VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE

K991551 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 143d

Cleared Sep 17, 1999

GAMMA-B 25-HYDROXY VITAMIN D RIA

K991998 · Immunodiagnostic Systems , Ltd.

MRG · System, Test, Vitamin D · 95d

Cleared Sep 17, 1999

MEDI-TEST COMBI 11

K991927 · Macherey-Nagel-Duren

JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 101d

Cleared Sep 17, 1999

DRX QT. HCG

K991532 · Metrika, Inc.

DHA · System, Test, Human Chorionic Gonadotropin · 137d

Cleared Sep 17, 1999

EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP

K991480 · Selfcare, Inc.

CGA · Glucose Oxidase, Glucose · 142d

Cleared Sep 15, 1999

CARESIDE CO2, TOTAL

K992475 · Careside, Inc.

KHS · Enzymatic, Carbon-dioxide · 51d

Cleared Sep 15, 1999

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

K992399 · Bayer Corp.

CIX · Bromcresol Green Dye-binding, Albumin · 58d

Cleared Sep 13, 1999

SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP

K992803 · Sigma Diagnostics, Inc.

CHH · Enzymatic Esterase--oxidase, Cholesterol · 25d

Cleared Sep 13, 1999

K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC

K992311 · Kamiya Biomedical Co.

DCK · C-reactive Protein, Antigen, Antiserum, And Control · 66d

Cleared Sep 09, 1999

CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772

K991834 · Cholestech Corp.

CKD · Hydrazone Colorimetry, Alt/sgpt · 104d

Cleared Sep 08, 1999

GO GLUCOSE MONITORING SYSTEM

K991754 · Lxn Corp.

CGA · Glucose Oxidase, Glucose · 107d

Cleared Sep 03, 1999

URINE CHEMISTRY CONTROL, LEVEL 2

K992578 · Consolidated Technologies, Inc.

JJW · Urinalysis Controls (assayed And Unassayed) · 32d

Cleared Sep 03, 1999

URINE CHEMISTRY CONTROL, LEVEL 1

K992576 · Consolidated Technologies, Inc.

JJW · Urinalysis Controls (assayed And Unassayed) · 32d

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