BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12— 510(k) K993571

Name: FDA 510(k) clearance K993571
Creator: U.S. Food and Drug Administration
Published: 1999-12-16

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K993571 for BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12, Substantially Equivalent on 1999-12-16. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code CDD
Device class: Class 2
Regulation: 21 CFR 862.1810
Advisory panel: Clinical Chemistry
Date received: 1999-10-21
Decision date: 1999-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

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