|
Device | cobas® EZH2 Mutation Test |
Generic Name | Somatic gene mutation detection system |
Applicant | Roche Molecular System, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 |
PMA Number | P200014 |
Supplement Number | S001 |
Date Received | 07/27/2020 |
Decision Date | 08/26/2020 |
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 Manufacturing process change to use an alternate filter |