ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
FDA 510(k) clearance K183592 · decided 2019-03-21
Clearance details
- K-number
- K183592
- Device name
- ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
- Applicant
- Beckman Coulter
- Decision
- Substantially Equivalent
- Date received
- 2018-12-21
- Decision date
- 2019-03-21
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PWD
- Device class
- 2
- Regulation number
- 864.7010
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M (DEN160047) | Beckman Coulter | 2017-06-29 |
Recalls involving this device
No recalls on record reference this clearance.