ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE— 510(k) K974342

Substantially Equivalent

Roche Molecular Systems, Inc.

FDA 510(k) clearance K974342 for ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE, Substantially Equivalent on 1999-05-28. Applicant: Roche Molecular Systems, Inc..

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code LSL
Advisory panel: Microbiology
Date received: 1997-11-18
Decision date: 1999-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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