Henry Schein 5700610
Henry Schein 5700610 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K143325 on 20 Aug 2015 and listed in FDA GUDID since 14 Nov 2017 (UDI-DI 00304040054185), 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 | Number00304040054185 | Date14 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143325 | Date20 Aug 2015 | StatusActive |
Official records
- AccessGUDID record 00304040054185
- FDA 510(k) database K143325
Across registries
- FDA 510(k) K143325 decided 20 Aug 2015 Active
- FDA GUDID UDI-DI 00304040054185 listed 14 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K143325
- Listed FDA GUDID 00304040054185
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Henry Schein
- Generic name
- Faecal occult blood IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- 5700610
- Primary DI / UDI-DI
- 00304040054185
- 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
Similar devices
Other devices filed under FDA product code KHE (REAGENT, OCCULT BLOOD).
- CAMCO R PAK-GUAIAC by Cambridge Chemical Products, Inc.
- COLONCARE by Care Products, Inc.
- HELENA BIO STRIP OB by Helena Laboratories, Corp.
- Instant-view-PLUS immunochemical Fecal Occult Blood Test by Alfa Scientific Designs, Inc.
- IMMUNOCCULT-LXI by Intl. Immunoassay Laboratories, Inc.
- Hema-Screen by IMMUNOSTICS, INC.
- Polymedco OC Light FOBT Test by POLYMEDCO, INC.
- HOME HEALTH CHEKUP KIT by Healthkit
- FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 by TECO DIAGNOSTICS