510(k) DEN160047
- Device
- ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
- Applicant
- Beckman Coulter
- 510(k) number
- DEN160047
- Product code
- PWD
- Decision
- Unknown (DENG)
- Decision date
- 2017-06-29
- Date received
- 2016-10-03
- Regulation
- 864.7010
- Classification name
- Flow Cytometric Test System For Hematopoietic Neoplasms
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Anthony Dennis
- Address
- 11800 SW 147th Ave. Miami FL US 33196 33196
FDA Registration Numbers#
- 1017835
- 1061932
- 3003244710
- 3016954941
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PWD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | Beckman Coulter | 2019-03-21 |