K052825

Substantially Equivalent

VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG

Applicant: Affinity Biologicals, Inc.
Product code: GGP
Advisory panel: Hematology
Date received: 2005-10-05
Decision date: 2006-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ancaster, Ontario, CA

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