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
11208 Chemistry devices
2676–2700 of 11208
Cleared Feb 20, 2004
AXSYM CORTISOL ASSAY
K033731 · Fujirebio Diagnostics,Inc.
JFT · Fluorometric, Cortisol · 84d
Cleared Feb 13, 2004
BAYER SPECIFIC PROTEIN REFERENCE SERUM
K033791 · Bayer Healthcare, LLC
JIX · Calibrator, Multi-analyte Mixture · 71d
Cleared Feb 12, 2004
LIAISON N-TACT PTH
K033426 · DiaSorin, Inc.
CEW · Radioimmunoassay, Parathyroid Hormone · 108d
Cleared Feb 12, 2004
LIAISON 25 OH VITAMIN D
K032844 · DiaSorin, Inc.
MRG · System, Test, Vitamin D · 154d
Cleared Feb 09, 2004
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K033674 · Seradyn, Inc.
LCP · Assay, Glycosylated Hemoglobin · 77d
Cleared Feb 04, 2004
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
K033706 · Polymedco, Inc.
LPS · Urinary Homocystine (nonquantitative) Test System · 70d
Cleared Feb 03, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
K033924 · Bio-Rad Laboratories, Inc.
DIF · Drug Mixture Control Materials · 47d
Cleared Jan 30, 2004
PICCOLO MAGNESIUM TEST SYSTEM
K040115 · Abaxis, Inc.
JGJ · Photometric Method, Magnesium · 10d
Cleared Jan 30, 2004
OLYMPUS URINE CALIBRATOR
K033910 · Cliniqa Corporation
JIX · Calibrator, Multi-analyte Mixture · 44d
Cleared Jan 30, 2004
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
K033606 · Axis-Shield Diagnostics, Ltd.
NBC · Test, Natriuretic Peptide · 74d
Cleared Jan 30, 2004
CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033058 · Diamond Diagnostics, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 123d
Cleared Jan 30, 2004
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
K033056 · Diamond Diagnostics, Inc.
CDS · Electrode, Ion Specific, Urea Nitrogen · 123d
Cleared Jan 30, 2004
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033055 · Diamond Diagnostics, Inc.
CGA · Glucose Oxidase, Glucose · 123d
Cleared Jan 28, 2004
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K032235 · Biosite Incorporated
NBC · Test, Natriuretic Peptide · 191d
Cleared Jan 26, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
K033302 · Nichols Institute Diagnostics
CEW · Radioimmunoassay, Parathyroid Hormone · 104d
Cleared Jan 22, 2004
N HIGH SENSITIVITY CRP
K033908 · Dade Behring, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 36d
Cleared Jan 21, 2004
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
K034055 · Diagnostic Products Corp.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 22d
Cleared Jan 16, 2004
E.P.T. PREGNANCY TEST
K033658 · Unipath , Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 56d
Cleared Jan 12, 2004
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
K033525 · Dade Behring, Inc.
DCF · Albumin, Antigen, Antiserum, Control · 66d
Cleared Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
K032334 · Roche Diagnostics Corp.
KLR · Enzyme Immunoassay, Lidocaine · 167d
Cleared Jan 08, 2004
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 28d
Cleared Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
K033937 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 19d
Cleared Jan 02, 2004
NOVA GLUCOSE CONTROL SOLUTIONS
K033433 · Nova Biomedical Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 66d
Cleared Dec 24, 2003
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
K033487 · Dade Behring, Inc.
MMI · Immunoassay Method, Troponin Subunit · 50d
Cleared Dec 23, 2003
TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200
K033383 · Biosite Incorporated
NBC · Test, Natriuretic Peptide · 61d

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All categories 11208 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 459 JJX Single (specified) Analyte Controls (assayed And Unassayed) 383 CGA Glucose Oxidase, Glucose 299 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 CIG Diazo Colorimetry, Bilirubin 217 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