ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION— 510(k) K925208

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K925208 for ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION, Substantially Equivalent on 1992-12-28. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code LGC
Advisory panel: Microbiology
Date received: 1992-09-28
Decision date: 1992-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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