K955638

Substantially Equivalent

SYNTHAFAX APTT REAGENT

Applicant: Ortho Diagnostic Systems, Inc.
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.