SYNTHASIL APTT REAGENT— 510(k) K953981

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K953981 for SYNTHASIL APTT REAGENT, Substantially Equivalent on 1995-11-30. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GFO
Advisory panel: Hematology
Date received: 1995-08-23
Decision date: 1995-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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