ORTHOKROME* FACTOR VIII— 510(k) K900395

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K900395 for ORTHOKROME* FACTOR VIII, Substantially Equivalent on 1990-03-15. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GGP
Advisory panel: Hematology
Date received: 1990-01-29
Decision date: 1990-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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