Rapid Response FOB-0MBC
by BTNX Inc
Rapid Response FOB-0MBC is a Class II device made by BTNX Inc, cleared under FDA 510(k) K110309 on 14 Sep 2011 and listed in FDA GUDID since 11 Oct 2019 (UDI-DI 00722066004999), 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 | Number00722066004999 | Date11 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110309 | Date14 Sep 2011 | StatusActive |
Official records
- AccessGUDID record 00722066004999
- FDA 510(k) database K110309
Across registries
- FDA 510(k) K110309 decided 14 Sep 2011 Active
- FDA GUDID UDI-DI 00722066004999 listed 11 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K110309
- Listed FDA GUDID 00722066004999
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rapid Response
- Generic name
- Faecal occult blood IVD, kit, rapid ICT, clinical
- Model / reference
- FOB-0MBC
- Primary DI / UDI-DI
- 00722066004999
- 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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- LIFEGUARD by Med-Tek Corp.
- FOB Rapid Test Cassette TFO-602 by Hangzhou Alltest Biotech.Co.,Ltd.