K990296

Substantially Equivalent

CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)

Applicant: Precision Biologic
Product code: GJT
Advisory panel: Hematology
Date received: 1999-01-28
Decision date: 1999-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, N.S., CA

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