Validation of the abi instruments and minor corrections to the instructions for use.
| Device | LeukoStrat CDx FLT3 Mutation Assay |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | INVIVOSCRIBE TECHNOLOGIES, INC |
| Date Received | 2017-12-22 |
| Decision Date | 2018-01-19 |
| PMA | P160040 |
| Supplement | S001 |
| Product Code | OWD |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 6330 Nancy Ridge Drive suite 106 san Diego, CA 92121 |
Supplemental Filings
| 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 |
NIH GUDID Devices