xReader System BS-0610S
xReader System BS-0610S (301) is a photometric/spectroscopic immunoassay analyser IVD (FDA Class II) made by Escreen, Inc., cleared under FDA 510(k) K140665 on 8 Dec 2014 (1 earlier submission) and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00867802000290), active as of 22 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 | Number00867802000290 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140665 | Date8 Dec 2014 | StatusActive |
Official records
- AccessGUDID record 00867802000290
- FDA 510(k) database K140665
- FDA 510(k) database K130082
Across registries
- FDA 510(k) K140665 decided 8 Dec 2014 Active
- FDA GUDID UDI-DI 00867802000290 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K130082
- Cleared FDA 510(k) K140665
- Listed FDA GUDID 00867802000290
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- xReader System
- Generic name
- Photometric/spectroscopic immunoassay analyser IVD
- Model / Ref / Catalog
- BS-0610S, 301
- Primary DI / UDI-DI
- 00867802000290
- FDA product code
- LDJ, LCM, JQT, DNK, DJR, DJG, DJC, DIS, DIO, DKZ, JXM
- GMDN term
- Photometric/spectroscopic immunoassay analyser IVD
- Device class
- Class II
- Regulation number
- 862.3870, 862.2400, 862.3640, 862.3620, 862.3650, 862.3610, 862.3150, 862.3250, 862.3100, 862.3170
- GUDID distribution status
- In Commercial Distribution