OC-Light S FBPU-BULKS
by Polymedco Cancer Diagnostic Products LLC
OC-Light S FBPU-BULKS is a Class II device made by Polymedco Cancer Diagnostic Products LLC, cleared under FDA 510(k) K143325 on 20 Aug 2015 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00855574005193), 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 | Number00855574005193 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143325 | Date20 Aug 2015 | StatusActive |
Official records
- AccessGUDID record 00855574005193
- FDA 510(k) database K143325
Across registries
- FDA 510(k) K143325 decided 20 Aug 2015 Active
- FDA GUDID UDI-DI 00855574005193 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K143325
- Listed FDA GUDID 00855574005193
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OC-Light S
- Generic name
- Faecal occult blood IVD, kit, rapid ICT, clinical
- Model / reference
- FBPU-BULKS
- Primary DI / UDI-DI
- 00855574005193
- 510(k) Number
- FDA product code
- KHE
- GMDN term
- Faecal occult blood IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 864.6550
- GUDID distribution status
- In Commercial Distribution
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