ORTHO CHLAMYDIA ANTIGEN ELISA TEST— 510(k) K921321

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K921321 for ORTHO CHLAMYDIA ANTIGEN ELISA TEST, Substantially Equivalent on 1992-08-11. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code LJC
Advisory panel: Microbiology
Date received: 1992-03-16
Decision date: 1992-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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