COBAS 4800 CT / NG TEST— 510(k) K110923

Substantially Equivalent

Roche Molecular Systems, Inc.

FDA 510(k) clearance K110923 for COBAS 4800 CT / NG TEST, Substantially Equivalent on 2012-01-24. Applicant: Roche Molecular Systems, Inc..

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code MKZ
Advisory panel: Microbiology
Date received: 2011-04-01
Decision date: 2012-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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