BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY— 510(k) K010668

Name: FDA 510(k) clearance K010668
Creator: U.S. Food and Drug Administration
Published: 2001-07-05

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K010668 for BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY, Substantially Equivalent on 2001-07-05. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2001-03-06
Decision date: 2001-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

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