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
11204 Chemistry devices
2151–2175 of 11204
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
Cleared Aug 16, 2006
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P
K060325 · Horiba Abx
CIG · Diazo Colorimetry, Bilirubin · 188d
Cleared Aug 14, 2006
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
K061885 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 42d
Cleared Aug 11, 2006
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
K061750 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 51d
Cleared Aug 11, 2006
ACON URINALYSIS REAGENT STRIPS
K061559 · Acon Laboratories Co.
CDM · Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) · 67d
Cleared Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 156d
Cleared Aug 08, 2006
DPC T60I KUSTI, MODEL 984248
K061107 · Thermo Electron OY
CEM · Electrode, Ion Specific, Potassium · 110d
Cleared Aug 08, 2006
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060318 · Horiba Abx
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 181d
Cleared Aug 07, 2006
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
K062055 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 18d
Cleared Aug 07, 2006
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061793 · Dade Behring, Inc.
JIY · Photometric Method, Iron (non-heme) · 42d
Cleared Aug 04, 2006
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
K061730 · Osmetech, Inc.
CEM · Electrode, Ion Specific, Potassium · 45d
Cleared Aug 02, 2006
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
K061703 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 47d
Cleared Jul 28, 2006
ACTIVE RENIN IRMA
K061758 · Diagnostic Systems Laboratories, Inc.
CIB · Radioimmunoassay, Angiotensin I And Renin · 36d
Cleared Jul 25, 2006
ELEMENT BLOOD GLUCOSE TEST SYSTEM
K060793 · Home Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 124d
Cleared Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683 · Roche Diagnostics Corp.
DDR · Myoglobin, Antigen, Antiserum, Control · 36d

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All categories 11204 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 247 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 175 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