ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL— 510(k) K940209

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K940209 for ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL, Substantially Equivalent on 1995-05-11. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GGN
Advisory panel: Hematology
Date received: 1994-01-14
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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