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 | S020 |
Date Received | 04/24/2019 |
Decision Date | 05/22/2019 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Changes in manufacturing gowning procedures. |
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