ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM— 510(k) K023184

Name: FDA 510(k) clearance K023184
Creator: U.S. Food and Drug Administration
Published: 2002-11-18

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K023184 for ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM, Substantially Equivalent on 2002-11-18. Applicant: Bayer Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 2002-09-24
Decision date: 2002-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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