BI-LEVEL ASSAYED TUMOR MARKER & ANTIN— 510(k) K821026

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K821026 for BI-LEVEL ASSAYED TUMOR MARKER & ANTIN, Substantially Equivalent on 1982-08-10. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1982-04-13
Decision date: 1982-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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