COBAS CT/NG V2.0 TEST— 510(k) K140887

Substantially Equivalent

Roche Molecular Systems, Inc.

FDA 510(k) clearance K140887 for COBAS CT/NG V2.0 TEST, Substantially Equivalent on 2014-05-05. Applicant: Roche Molecular Systems, Inc..

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code LSL
Advisory panel: Microbiology
Date received: 2014-04-07
Decision date: 2014-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

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