The following data is part of a De Novo classification by Beckman Coulter with the FDA for Clearllab T1, Clearllab T2, Clearllab B1, Clearllab B2, Clearllab M.
| DeNovo ID | DEN160047 |
| Device Name: | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M |
| Classification | Flow Cytometric Test System For Hematopoietic Neoplasms |
| Applicant | Beckman Coulter 11800 Sw 147th Ave Miami, FL 33196 |
| Contact | Anthony Dennis |
| Product Code | PWD |
| CFR Regulation Number | 864.7010 [🔎] |
| 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 | Immunology |
| Classification Advisory | Hematology |
| Type | Direct |
| Date Received | 2016-10-03 |
| Decision Date | 2017-06-29 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590671013 | DEN160047 | 000 |
| 15099590671006 | DEN160047 | 000 |
| 15099590670993 | DEN160047 | 000 |
| 15099590670986 | DEN160047 | 000 |
| 15099590670979 | DEN160047 | 000 |