URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM— 510(k) K022096

Name: FDA 510(k) clearance K022096
Creator: U.S. Food and Drug Administration
Published: 2003-03-18

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K022096 for URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, Substantially Equivalent on 2003-03-18. Applicant: Bayer Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 2002-06-27
Decision date: 2003-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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