ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY— 510(k) K011963

Name: FDA 510(k) clearance K011963
Creator: U.S. Food and Drug Administration
Published: 2001-11-20

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K011963 for ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY, Substantially Equivalent on 2001-11-20. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code CFR
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2001-06-22
Decision date: 2001-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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