MyCare Psychiatry Clozapine Assay Kit
Clozapine Test System
Saladax Biomedical Inc
The following data is part of a De Novo classification by Saladax Biomedical Inc with the FDA for Mycare Psychiatry Clozapine Assay Kit.
Pre-market Notification Details
| DeNovo ID | DEN190028 |
| Device Name: | MyCare Psychiatry Clozapine Assay Kit |
| Classification | Clozapine Test System |
| Applicant | Saladax Biomedical Inc 116 Research Drive Bethlehem, PA 18015 |
| Contact | Sue Werner |
| Product Code | QKT |
| CFR Regulation Number | 862.3245 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Toxicology |
| Classification Advisory | Clinical Chemistry |
| Type | Direct |
| Date Received | 2019-05-24 |
| Decision Date | 2020-04-16 |
| Reclassification Order: | Reclassification Order |
NIH GUDID Devices
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.