ORTHOKROME* ANTITHROMBIN— 510(k) K900400

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K900400 for ORTHOKROME* ANTITHROMBIN, Substantially Equivalent on 1990-03-15. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code JBQ
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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