ADVIA CENTAUR RUBELLA IGG ASSAY— 510(k) K003412

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K003412 for ADVIA CENTAUR RUBELLA IGG ASSAY, Substantially Equivalent on 2001-04-13. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code LFX
Advisory panel: Microbiology
Date received: 2000-11-02
Decision date: 2001-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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