VISULIZE FACTOR IX ANTIGEN KIT— 510(k) K051054

Substantially Equivalent

Affinity Biologicals, Inc.

FDA 510(k) clearance K051054 for VISULIZE FACTOR IX ANTIGEN KIT, Substantially Equivalent on 2005-06-29. Applicant: Affinity Biologicals, Inc..

Clearance details

Applicant: Affinity Biologicals, Inc.
Product code: Code GGP
Advisory panel: Hematology
Date received: 2005-04-26
Decision date: 2005-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ancaster, Ontario, CA

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