QUANTITATIVE FIBRINOGEN ASSAY— 510(k) K963902

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K963902 for QUANTITATIVE FIBRINOGEN ASSAY, Substantially Equivalent on 1996-11-29. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GIS
Advisory panel: Hematology
Date received: 1996-09-27
Decision date: 1996-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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