cobas CTNG for use on cobas 6800/8800 systems— 510(k) K202408

Substantially Equivalent

Roche Molecular Systems, Inc.

FDA 510(k) clearance K202408 for cobas CTNG for use on cobas 6800/8800 systems, Substantially Equivalent on 2021-01-21. Applicant: Roche Molecular Systems, Inc..

Clearance details

Applicant
Roche Molecular Systems, Inc.
Product code
Code QEP
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasanton, CA, US
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