|
Device | therascreen PIK3CA RGQ PCR Kit |
Generic Name | Somatic gene mutation detection system |
Applicant | QIAGEN GMBH Qiagen Strasse 1 Hilden 40724 |
PMA Number | P190001 |
Supplement Number | S001 |
Date Received | 03/04/2020 |
Decision Date | 04/03/2020 |
Product Code |
OWD |
Advisory Committee |
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Changes to in-process QC testing. |