ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST— 510(k) K853738

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K853738 for ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST, Substantially Equivalent on 1985-12-06. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

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

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