N Flc Control SL2 10873663
by Siemens Healthcare Diagnostics Products Ltd
N Flc Control SL2 10873663 (OPJF05) is a Class II device made by Siemens Healthcare Diagnostics Products Ltd, cleared under FDA 510(k) K171742 on 17 Nov 2017 and listed in FDA GUDID since 8 Oct 2018 (UDI-DI 00630414237503), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00630414237503 | Date8 Oct 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171742 | Date17 Nov 2017 | StatusActive |
Official records
- AccessGUDID record 00630414237503
- FDA 510(k) database K171742
Across registries
- FDA 510(k) K171742 decided 17 Nov 2017 Active
- FDA GUDID UDI-DI 00630414237503 listed 8 Oct 2018 Listed
Timeline
- Cleared FDA 510(k) K171742
- Listed FDA GUDID 00630414237503
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- N Flc Control SL2
- Generic name
- Kappa/lambda light chain immunoglobulin IVD, control
- Model / Ref / Catalog
- 10873663, OPJF05
- Primary DI / UDI-DI
- 00630414237503
- 510(k) Number
- FDA product code
- DEH, DFH
- GMDN term
- Kappa/lambda light chain immunoglobulin IVD, control
- Device class
- Class II
- Regulation number
- 866.5550
- GUDID distribution status
- In Commercial Distribution
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