The following data is part of a premarket notification filed by Beckman Coulter with the FDA for Clearllab 10c Panels (b, T, M1, M2), Navios Flow Cytometer, Navios Ex Flow Cytometer.
| Device ID | K183592 |
| 510k Number | K183592 |
| Device Name: | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer |
| Classification | Flow Cytometric Test System For Hematopoietic Neoplasms |
| Applicant | Beckman Coulter 11800 SW 147th Ave. Miami, FL 33196 -2500 |
| Contact | Anthony Dennis |
| Correspondent | Anthony Dennis Beckman Coulter 11800 SW 147th Ave. Miami, FL 33196 -2500 |
| Product Code | PWD |
| CFR Regulation Number | 864.7010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590701505 | K183592 | 000 |
| 15099590701499 | K183592 | 000 |
| 15099590701482 | K183592 | 000 |
| 15099590701475 | K183592 | 000 |
| 15099590694982 | K183592 | 000 |
| 15099590694975 | K183592 | 000 |
| 15099590694968 | K183592 | 000 |