ORTHO DNA PROBE HSV CONFIRMATION TEST— 510(k) K852360

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K852360 for ORTHO DNA PROBE HSV CONFIRMATION TEST, Substantially Equivalent on 1985-09-12. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GQL
Advisory panel: Microbiology
Date received: 1985-06-04
Decision date: 1985-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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