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
2276–2300 of 13257
Cleared Sep 15, 2006
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
K061190 · Beckman Coulter, Inc.
CEW · Radioimmunoassay, Parathyroid Hormone · 140d
Cleared Sep 13, 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
K062319 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 35d
Cleared Sep 11, 2006
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239 · Roche Diagnostics Corp.
CFR · Hexokinase, Glucose · 40d
Cleared Sep 11, 2006
MODIFICATION TO DIADEXUS PLAC TEST
K062234 · Diadexus, Inc.
NOE · Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 · 40d
Cleared Sep 11, 2006
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
K062058 · Bayer Healthcare
NBW · System, Test, Blood Glucose, Over The Counter · 53d
Cleared Sep 11, 2006
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
K061802 · Dade Behring, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 76d
Cleared Sep 11, 2006
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795 · Dade Behring, Inc.
NBC · Test, Natriuretic Peptide · 80d
Cleared Sep 06, 2006
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316 · Dade Behring, Inc.
JIF · Enzymatic Method, Ammonia · 28d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
K062034 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 49d
Cleared Sep 06, 2006
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
K061825 · Dade Behring, Inc.
DCN · System, Test, C-reactive Protein · 70d
Cleared Sep 06, 2006
URYXXON RELAX URINE ANALYZER
K061742 · Macherey-Nagel GmbH & Co. KG
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 78d
Cleared Sep 06, 2006
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712
K060765 · Hemocue AB
LFR · Glucose Dehydrogenase, Glucose · 169d
Cleared Aug 30, 2006
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
K060578 · Scantibodies Laboratory, Inc.
JKR · Radioimmunoassay, Calcitonin · 177d
Cleared Aug 29, 2006
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
K061839 · Dade Behring, Inc.
CIG · Diazo Colorimetry, Bilirubin · 61d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
K062122 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 31d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
K062121 · Dade Behring, Inc.
DKB · Calibrators, Drug Mixture · 31d
Cleared Aug 25, 2006
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
K061923 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 49d
Cleared Aug 25, 2006
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR
K061719 · Dade Behring, Inc.
CIG · Diazo Colorimetry, Bilirubin · 67d
Cleared Aug 25, 2006
N LATEX CDT
K060677 · Dade Behring, Inc.
NAO · Test, Carbohydrate Deficient Transferrin · 164d
Cleared Aug 24, 2006
ABX PENTRA 400: LIPOPROTEINS
K060854 · Horiba Abx
JIT · Calibrator, Secondary · 148d
Cleared Aug 21, 2006
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K062236 · Dade Behring, Inc.
MKW · Cyclosporine · 19d
Cleared Aug 21, 2006
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
K062128 · Dade Behring, Inc.
JHS · Differential Rate Kinetic Method, Cpk Or Isoenzymes · 26d
Cleared Aug 21, 2006
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
K061838 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 53d
Cleared Aug 16, 2006
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K062195 · Lifescan, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 15d
Cleared Aug 16, 2006
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
K062152 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 20d

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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