BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)— 510(k) K982328

Name: FDA 510(k) clearance K982328
Creator: U.S. Food and Drug Administration
Published: 1999-01-29

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K982328 for BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), Substantially Equivalent on 1999-01-29. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code CJO
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1998-07-02
Decision date: 1999-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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