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.

13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
2676–2700 of 13257
Cleared Nov 18, 2004
QUIKREAD CRP CALIBRATOR SET
K042625 · Orion Diagnostica, OY
JJY · Multi-analyte Controls, All Kinds (assayed) · 52d
Cleared Nov 18, 2004
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
K042521 · Ortho-Clinical Diagnostics, Inc.
JIT · Calibrator, Secondary · 63d
Cleared Nov 17, 2004
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
K042459 · Beckman Coulter, Inc.
LCP · Assay, Glycosylated Hemoglobin · 68d
Cleared Nov 16, 2004
MULTI-CHEM CALIBRATOR A
K042551 · Wako Chemicals USA, Inc.
JIX · Calibrator, Multi-analyte Mixture · 57d
Cleared Nov 12, 2004
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
K042291 · Beckman Coulter, Inc.
CEM · Electrode, Ion Specific, Potassium · 80d
Cleared Nov 08, 2004
MULTI-LIPID CALIBRATOR
K042550 · Wako Chemicals USA, Inc.
JIX · Calibrator, Multi-analyte Mixture · 49d
Cleared Nov 08, 2004
MULTI CHEM CAL B
K042549 · Wako Chemicals USA, Inc.
JIX · Calibrator, Multi-analyte Mixture · 49d
Cleared Nov 05, 2004
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
K042717 · Medical Analysis Systems, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 36d
Cleared Nov 03, 2004
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
K042307 · Seradyn, Inc.
JIT · Calibrator, Secondary · 70d
Cleared Nov 02, 2004
LIQUICHEK ELEVATED CRP CONTROL
K042837 · Bio-Rad
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 19d
Cleared Nov 02, 2004
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446 · Bio-Rad Laboratories, Inc.
JJW · Urinalysis Controls (assayed And Unassayed) · 54d
Cleared Oct 29, 2004
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
K042485 · Roche Diagnostics Corp.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 46d
Cleared Oct 29, 2004
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
K042448 · General Atomics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 50d
Cleared Oct 29, 2004
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
K042193 · Diazyme Laboratories
LCP · Assay, Glycosylated Hemoglobin · 78d
Cleared Oct 29, 2004
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
K042191 · Diazyme Laboratories
MZV · Test, System, Potassium, Enzymatic Method · 78d
Cleared Oct 29, 2004
HDL-EX SEIKEN ASSAY KIT
K041090 · Denka Seiken Co., Ltd.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 186d
Cleared Oct 28, 2004
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE
K042006 · Ortho-Clinical Diagnostics, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 94d
Cleared Oct 28, 2004
BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
K041478 · Becton Dickinson
CGA · Glucose Oxidase, Glucose · 147d
Cleared Oct 28, 2004
BIO-CHEM ANALYZER, MODEL 100
K040750 · Clinical Analysis Corporation, Inc.
CEM · Electrode, Ion Specific, Potassium · 219d
Cleared Oct 27, 2004
GLUCOSE TOLERANCE BEVERAGE
K042183 · Ever Scientific
MRV · Drink, Glucose Tolerance · 77d
Cleared Oct 19, 2004
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
K040866 · Armkel, LLC
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 200d
Cleared Oct 15, 2004
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
K041975 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 85d
Cleared Oct 15, 2004
LIQUI-HEME GLYCO A1C ASSAY
K031296 · Biodiagnostic Intl
LCP · Assay, Glycosylated Hemoglobin · 541d
Cleared Oct 08, 2004
ABL800 FLEX
K041874 · Radiometer Medical Aps
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 88d
Cleared Oct 07, 2004
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
K042324 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 41d

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All categories 13257 JJY Multi-analyte Controls, All Kinds (assayed) 554 NBW System, Test, Blood Glucose, Over The Counter 513 JJX Single (specified) Analyte Controls (assayed And Unassayed) 409 CGA Glucose Oxidase, Glucose 391 JHI Visual, Pregnancy Hcg, Prescription Use 359 JIX Calibrator, Multi-analyte Mixture 271 CIG Diazo Colorimetry, Bilirubin 234 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 226 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 JIT Calibrator, Secondary 224 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 223 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 199 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 183 JGS Electrode, Ion Specific, Sodium 162