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
11215 Chemistry devices
2926–2950 of 11215
Cleared Sep 05, 2002
PICCOLO PHOSPHORUS TEST SYSTEM
K022312 · Abaxis, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 50d
Cleared Sep 03, 2002
RAICHEM LIPID CALIBRATOR
K022767 · Hemagen Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 13d
Cleared Aug 30, 2002
RANDOX LIPID CONTROL
K022591 · Randox Laboratories, Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 25d
Cleared Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · Roche Diagnostics Corp.
JHY · Colorimetric Method, Cpk Or Isoenzymes · 20d
Cleared Aug 27, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K022491 · Cliniqa Corporation
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Aug 23, 2002
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538 · Diagnostic Chemicals, Ltd. (Usa)
JIR · Indicator Method, Protein Or Albumin (urinary, Non-quant.) · 22d
Cleared Aug 23, 2002
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K021819 · Lifescan, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 80d
Cleared Aug 22, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438
K022707 · Bio-Rad
DIF · Drug Mixture Control Materials · 8d
Cleared Aug 21, 2002
PTS PANELS MULTI-CHEMISTRY CONTROLS
K022401 · Polymer Technology Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 29d
Cleared Aug 16, 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960 · Abbott Laboratories
LFR · Glucose Dehydrogenase, Glucose · 63d
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
K022529 · Bio-Rad
JJS · Controls For Blood-gases, (assayed And Unassayed) · 15d
Cleared Aug 15, 2002
SPIFE LIPPOROTEIN-12, MODEL 3344
K022333 · Helena Laboratories
JHO · Electrophoretic Separation, Lipoproteins · 28d
Cleared Aug 08, 2002
BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538
K022426 · Becton, Dickinson & CO
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 14d
Cleared Aug 01, 2002
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
K022232 · Cliniqa Corporation
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 22d
Cleared Jul 29, 2002
BD VACUTAINER PLUS PST II TUBE
K022130 · Becton, Dickinson & CO
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 28d
Cleared Jul 29, 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · Hemagen Diagnostics, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 105d
Cleared Jul 25, 2002
STAT PROFILE PHOX PLUS C ANALYZER
K021713 · Nova Biomedical Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 63d
Cleared Jul 25, 2002
K-ASSAY LP(A) ASSAY
K021660 · Kamiya Biomedical Co.
DFC · Lipoprotein, Low-density, Antigen, Antiserum, Control · 66d
Cleared Jul 25, 2002
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2
K021316 · Genzyme Corp.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 91d
Cleared Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
K022171 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 20d
Cleared Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
K022118 · Diagnostic Products Corp.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 21d
Cleared Jul 19, 2002
MODIFICATION TO RAICHEM CALCIUM REAGENT
K022049 · Hemagen Diagnostics, Inc.
CJY · Azo Dye, Calcium · 25d
Cleared Jul 19, 2002
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671 · Jas Diagnostics, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 59d
Cleared Jul 19, 2002
CHEMWELL, ALSO KNOWN AS PROJECT 2900
K013420 · Awareness Technology, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 277d
Cleared Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
K021326 · bioMerieux, Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 83d

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All categories 11215 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 461 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 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