K981174

Substantially Equivalent

CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)

Applicant: Precision Biologicals, Inc.
Product code: GJT
Advisory panel: Hematology
Date received: 1998-04-01
Decision date: 1999-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, Nova Scotia, CA

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