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 | LeukoStrat CDx FLT3 Mutation Assay |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | INVIVOSCRIBE TECHNOLOGIES, INC10222 Barnes Canyon Road, Building 1san Diego, CA 92121 PMA NumberP160040 Supplement NumberS010 Date Received03/15/2022 Decision Date04/11/2022 Product Code OWD Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-15 |
| Decision Date | 2022-04-11 |
| PMA | P160040 |
| Supplement | S010 |
| 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 | INVIVOSCRIBE TECHNOLOGIES, INC 10222 Barnes Canyon Road, Building 1 san Diego, CA 92121 PMA NumberP160040 Supplement NumberS010 Date Received03/15/2022 Decision Date04/11/2022 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 change Of Contractor Mycoplasma Testing Method For Invivoscribe Cell Lines |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160040 | Original Filing | |
| S010 | 2022-03-15 | 30-day Notice |
| S009 | 2021-07-12 | 30-day Notice |
| S008 | 2021-07-09 | Special (immediate Track) |
| S007 | ||
| S006 | 2019-10-17 | Normal 180 Day Track |
| S005 | ||
| S004 | 2018-11-06 | Real-time Process |
| S003 | 2018-04-12 | Normal 180 Day Track No User Fee |
| S002 | 2018-03-30 | Normal 180 Day Track |
| S001 | 2017-12-22 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00850052003685 | P160040 | 004 |
| 00850052003739 | P160040 | 006 |
| 00810022732571 | P160040 | 006 |