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.
| Device | therascreen KRAS RGQ PCR Kit |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN GmbHqiagen Strasse 1hilden 40724 PMA NumberP110027 Supplement NumberS015 Date Received06/15/2022 Decision Date07/11/2022 Product Code OWD Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-15 |
| Decision Date | 2022-07-11 |
| PMA | P110027 |
| Supplement | S015 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN GmbH qiagen Strasse 1 hilden 40724 PMA NumberP110027 Supplement NumberS015 Date Received06/15/2022 Decision Date07/11/2022 Product Code OWD Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Addition Of A Calibration Step For Manufacturing Internal Control |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110027 | Original Filing | |
| S015 | 2022-06-15 | 30-day Notice |
| S014 | 2022-05-19 | Special (immediate Track) |
| S013 | ||
| S012 | 2021-02-10 | Panel Track |
| S011 | 2020-03-04 | 30-day Notice |
| S010 | 2018-03-08 | 30-day Notice |
| S009 | 2015-08-18 | Normal 180 Day Track No User Fee |
| S008 | 2015-02-18 | Normal 180 Day Track |
| S007 | 2015-01-26 | Real-time Process |
| S006 | 2015-01-26 | Real-time Process |
| S005 | 2015-01-21 | 30-day Notice |
| S004 | 2015-01-21 | 30-day Notice |
| S003 | 2014-12-22 | 30-day Notice |
| S002 | 2014-12-15 | 30-day Notice |
| S001 |