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
11214 Chemistry devices
Cleared
Feb 24, 2003
WAKO L-TYPE GLUCOSE 2
CFR
Hexokinase, Glucose
63d
Cleared
Feb 21, 2003
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
NBC
Test, Natriuretic Peptide
24d
Cleared
Feb 21, 2003
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
DIH
Colorimetry, Cholinesterase
46d
Cleared
Feb 21, 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
MMI
Immunoassay Method, Troponin Subunit
63d
Cleared
Feb 12, 2003
WIENER LAB. BILIRUBINA DIRECT AA
CIG
Diazo Colorimetry, Bilirubin
61d
Cleared
Feb 12, 2003
WIENER LAB COLINESTERASA AA
DIH
Colorimetry, Cholinesterase
72d
Cleared
Feb 11, 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
JHI
Visual, Pregnancy Hcg, Prescription Use
77d
Cleared
Feb 07, 2003
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
NBW
System, Test, Blood Glucose, Over The Counter
49d
Cleared
Jan 31, 2003
SETPOINT CHEMISTRY CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
14d
Cleared
Jan 28, 2003
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS
JJY
Multi-analyte Controls, All Kinds (assayed)
13d
Cleared
Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
77d
Cleared
Jan 24, 2003
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
JJT
Enzyme Controls (assayed And Unassayed)
14d
Cleared
Jan 24, 2003
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
CHH
Enzymatic Esterase--oxidase, Cholesterol
86d
Cleared
Jan 24, 2003
PICCOLO HDL TEST SYSTEM
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
86d
Cleared
Jan 24, 2003
PICCOLO TRIGLYCERIDES TEST SYSTEM
JGY
Colorimetric Method, Triglycerides
86d
Cleared
Jan 23, 2003
TRIAGE CARDIAC CONTROLS
JJY
Multi-analyte Controls, All Kinds (assayed)
13d
Cleared
Jan 23, 2003
ASCENSIA GLUCOFACTS
NBW
System, Test, Blood Glucose, Over The Counter
31d
Cleared
Jan 17, 2003
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS
JJY
Multi-analyte Controls, All Kinds (assayed)
7d
Cleared
Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
JHX
Fluorometric Method, Cpk Or Isoenzymes
15d
Cleared
Jan 17, 2003
GLUCOSE-SL-C ASSAY, MODEL 257-30
CFR
Hexokinase, Glucose
71d
Cleared
Jan 16, 2003
GENZYME CONTRAST II HCG URINE/SERUM TEST
JHI
Visual, Pregnancy Hcg, Prescription Use
86d
Cleared
Jan 13, 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
LCP
Assay, Glycosylated Hemoglobin
66d
Cleared
Jan 07, 2003
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
CKB
Acid Phosphatase, Naphthyl Phosphate
50d
Cleared
Jan 06, 2003
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
JJY
Multi-analyte Controls, All Kinds (assayed)
88d
Cleared
Jan 03, 2003
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
JHW
U.v. Method, Cpk Isoenzymes
57d
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