VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG— 510(k) K052825

Name: FDA 510(k) clearance K052825
Creator: U.S. Food and Drug Administration
Published: 2006-01-20

Substantially Equivalent

Affinity Biologicals, Inc.

FDA 510(k) clearance K052825 for VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG, Substantially Equivalent on 2006-01-20. Applicant: Affinity Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Affinity Biologicals, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2005-10-05
Decision date: 2006-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ancaster, Ontario, CA

Download summary PDF View on FDA.gov ↗

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