|
Device | cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v2 |
Generic Name | Somatic gene mutation detection system |
Applicant | ROCHE 4300 HACIENDA DRIVE PO BOX 9002 PLEASANTON, CA 94588 |
PMA Number | P120019 |
Supplement Number | S012 |
Date Received | 09/22/2016 |
Decision Date | 10/19/2016 |
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 Implementation of AQL sampling in place of 100% visual inspection for filling line. |