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
3151–3175 of 11219
Cleared May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520 · Instrumentation Laboratory CO
CGA · Glucose Oxidase, Glucose · 74d
Cleared May 02, 2001
RAICHEM CREATININE URINE STANDARD
K011126 · Hemagen Diagnostics, Inc.
JIT · Calibrator, Secondary · 19d
Cleared Apr 30, 2001
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
K004038 · Scantibodies Laboratory, Inc.
CEW · Radioimmunoassay, Parathyroid Hormone · 123d
Cleared Apr 26, 2001
PICCOLO CHLORIDE TEST SYSTEM
K010670 · Abaxis, Inc.
CHJ · Mercuric Thiocyanate, Colorimetry, Chloride · 51d
Cleared Apr 26, 2001
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
K004010 · Roche Diagnostics Corp.
LFR · Glucose Dehydrogenase, Glucose · 121d
Cleared Apr 26, 2001
URS-1K (KETONE TESST)
K003987 · Teco Diagnostics
JIN · Nitroprusside, Ketones (urinary, Non-quant.) · 121d
Cleared Apr 20, 2001
DIMENSION CTNI CALIBRATOR
K010314 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 77d
Cleared Apr 20, 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313 · Dade Behring, Inc.
MMI · Immunoassay Method, Troponin Subunit · 77d
Cleared Apr 13, 2001
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
K010812 · Syva Co., Dade Behring, Inc.
LAR · Enzyme Immunoassay, Procainamide · 25d
Cleared Apr 13, 2001
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
K010421 · Wiener Laboratories Saic
KNK · Acid, Uric, Uricase (colorimetric) · 60d
Cleared Apr 05, 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · Sa Scientific, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 36d
Cleared Mar 30, 2001
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652 · Sigma Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 25d
Cleared Mar 29, 2001
BAYER ADVIA IMS SYSTEM
K010201 · Bayer Corp.
MMI · Immunoassay Method, Troponin Subunit · 66d
Cleared Mar 26, 2001
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700
K010403 · Home Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 42d
Cleared Mar 23, 2001
JAS MAGNESIUM REAGENT
K003835 · Jas Diagnostics, Inc.
JGJ · Photometric Method, Magnesium · 101d
Cleared Mar 19, 2001
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052 · Respironics, Inc.
MQM · Bilirubin (total And Unbound) In The Neonate Test System · 70d
Cleared Mar 19, 2001
ACCU-CHEK INFORM METER
K003846 · Roche Diagnostics Corp.
LFR · Glucose Dehydrogenase, Glucose · 97d
Cleared Mar 16, 2001
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
K010266 · Biosite Incorporated
NBC · Test, Natriuretic Peptide · 46d
Cleared Mar 16, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · Dade Behring, Inc.
KHS · Enzymatic, Carbon-dioxide · 52d
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 122d
Cleared Mar 15, 2001
RANDOX GLUCOSE (GOD/PAP)
K003346 · Randox Laboratories, Ltd.
CGA · Glucose Oxidase, Glucose · 141d
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · Dade Behring, Inc.
CEM · Electrode, Ion Specific, Potassium · 65d
Cleared Mar 13, 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
K010428 · Beckman Coulter, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d
Cleared Mar 13, 2001
N LATEX CYSTATIN C
K003503 · Dade Behring, Inc.
NDY · Test, Cystatin C · 120d
Cleared Mar 07, 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · Roche Diagnostics Corp.
LFR · Glucose Dehydrogenase, Glucose · 29d

Looking for a specific chemistry device? Search by device name, K-number or manufacturer.

Search all Chemistry 510(k) devices

Filter by Product Code

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