510(k) K955638— SYNTHAFAX APTT REAGENT

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GFO
Advisory panel: Hematology
Date received: 1995-12-11
Decision date: 1996-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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