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
11219 Chemistry devices
3201–3225 of 11219
Cleared Dec 19, 2000
BAYER RAPIDPOINT 400 SYSTEM
K002738 · Bayer Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 109d
Cleared Dec 18, 2000
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K003721 · Olympus America, Inc.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 14d
Cleared Dec 18, 2000
ROCHE DIAGNOSTICS CK-MB
K003158 · Roche Diagnostics Corp.
JHW · U.v. Method, Cpk Isoenzymes · 69d
Cleared Dec 18, 2000
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441 · Lifescan, Inc.
CGA · Glucose Oxidase, Glucose · 224d
Cleared Dec 14, 2000
CREATININE
K003247 · Jas Diagnostics, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 58d
Cleared Dec 14, 2000
ELECSYS HCG AND BETA TEST SYSTEM
K003178 · Roche Diagnostics Corp.
DHA · System, Test, Human Chorionic Gonadotropin · 64d
Cleared Dec 05, 2000
ALBUMIN
K003327 · Jas Diagnostics, Inc.
CIX · Bromcresol Green Dye-binding, Albumin · 42d
Cleared Dec 05, 2000
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
K002128 · Diagnostic Systems Laboratories, Inc.
NDR · Enzyme Immunoassay, Inhibin-a · 144d
Cleared Dec 05, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
K000582 · Abbott Diabetes Care, Inc.
LFR · Glucose Dehydrogenase, Glucose · 287d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
K003242 · Bio-Rad
JJS · Controls For Blood-gases, (assayed And Unassayed) · 44d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
K003239 · Bio-Rad
JJS · Controls For Blood-gases, (assayed And Unassayed) · 44d
Cleared Nov 27, 2000
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093 · Diagnostic Chemicals , Ltd.
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 55d
Cleared Nov 27, 2000
N/T PROTEIN CONTROL SL
K002852 · Dade Behring, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 75d
Cleared Nov 20, 2000
ACCESS ULTRASENSITIVE HGH CALIBRATORS
K003098 · Beckman Coulter, Inc.
JIT · Calibrator, Secondary · 48d
Cleared Nov 20, 2000
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K002199 · Pointe Scientific, Inc.,
CFR · Hexokinase, Glucose · 123d
Not Cleared Nov 20, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
DEN000010 · Biosite Incorporated
NBC · Test, Natriuretic Peptide · 5d
Cleared Nov 16, 2000
CREATININE PLUS
K003261 · Roche Diagnostics Corp.
JFY · Enzymatic Method, Creatinine · 29d
Cleared Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993 · Abbott Laboratories
LFR · Glucose Dehydrogenase, Glucose · 137d
Cleared Nov 08, 2000
CARESIDE CHOLINESTERASE
K002792 · Careside, Inc.
DIH · Colorimetry, Cholinesterase · 62d
Cleared Nov 02, 2000
ACCUWELL TSH, MODEL KAW-TSH-960
K001455 · Neometrics, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 177d
Cleared Oct 25, 2000
RAICHEM PHOSPORUS REAGENT
K003012 · Hemagen Diagnostics, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 29d
Cleared Oct 25, 2000
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K002982 · Olympus America, Inc.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 30d
Cleared Oct 19, 2000
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613 · Nova Biomedical Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 58d
Cleared Oct 13, 2000
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651 · Pointe Scientific, Inc.,
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 49d
Cleared Oct 11, 2000
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · Dade Behring, Inc.
LDP · Colorimetry, Acetaminophen · 55d

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All categories 11219 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 462 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 300 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