KOAGULAB* 32-S COAGULATION SYSTEM— 510(k) K885035

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K885035 for KOAGULAB* 32-S COAGULATION SYSTEM, Substantially Equivalent on 1989-02-03. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GKP
Advisory panel: Hematology
Date received: 1988-12-05
Decision date: 1989-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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