ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION— 510(k) K910668

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K910668 for ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION, Substantially Equivalent on 1991-03-19. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code LJC
Advisory panel: Microbiology
Date received: 1991-02-13
Decision date: 1991-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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