AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM— 510(k) K972462

Name: FDA 510(k) clearance K972462
Creator: U.S. Food and Drug Administration
Published: 1997-09-22

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K972462 for AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM, Substantially Equivalent on 1997-09-22. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code LOJ
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1997-07-01
Decision date: 1997-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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