InSure FIT 01
InSure FIT 01 (80025) is a Class II device made by Enterix Inc., cleared under FDA 510(k) K002457 on 12 Jan 2001 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00850093003019), 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 | Number00850093003019 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK002457 | Date12 Jan 2001 | StatusActive |
Official records
- AccessGUDID record 00850093003019
- FDA 510(k) database K002457
Across registries
- FDA 510(k) K002457 decided 12 Jan 2001 Active
- FDA GUDID UDI-DI 00850093003019 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K002457
- Listed FDA GUDID 00850093003019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- InSure FIT
- Generic name
- Faecal occult blood IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- 01, 80025
- Primary DI / UDI-DI
- 00850093003019
- 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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