K110432

Substantially Equivalent

VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN

Applicant: Affinity Biologicals, Inc.
Product code: GGN
Advisory panel: Hematology
Date received: 2011-02-15
Decision date: 2011-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ancaster, Ontario, CA

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