|
Device | Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test |
Generic Name | Somatic gene mutation detection system |
Applicant | ROCHE 4300 HACIENDA DRIVE PO BOX 9002 PLEASANTON, CA 94588 |
PMA Number | P120019 |
Supplement Number | S017 |
Date Received | 10/30/2017 |
Decision Date | 11/13/2017 |
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 Scale-up production of a bulk reagent. |