COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS— 510(k) K053287

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K053287 for COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS, Substantially Equivalent on 2006-08-10. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code MKZ
Advisory panel: Microbiology
Date received: 2005-11-25
Decision date: 2006-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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