Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | COBAS KRAS MUTATION TEST |
Generic Name | Somatic gene mutation detection system |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P140023 |
Supplement Number | S003 |
Date Received | 01/28/2016 |
Decision Date | 04/25/2016 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the proposed formulation change (removal of anti-microbial agent ProClin 300) and process changes to production of KRAS reaction Mix, a component of cobas® KRAS Mutation Test. |
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