Henry Schein 5701172
Henry Schein 5701172 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 24 Feb 2020 (UDI-DI 10304040102517), 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 | Number10304040102517 | Date24 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143325 | Date20 Aug 2015 | StatusActive |
Official records
- AccessGUDID record 10304040102517
- FDA 510(k) database K143325
Across registries
- FDA 510(k) K143325 decided 20 Aug 2015 Active
- FDA GUDID UDI-DI 10304040102517 listed 24 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K143325
- Listed FDA GUDID 10304040102517
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- Withdrawn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
- 5701172
- Primary DI / UDI-DI
- 10304040102517
- 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).
- COLOTRAK OCCULT BLOOD TEST by Breit Laboratories, Inc.
- HEMA SCREEN SPECIFIC IFOBT by IMMUNOSTICS, INC.
- DBEST OCCULT BLOOD TEST KIT by Ameritek, Inc.
- IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 by Ind Diagnostic, Inc.
- FLEXSURE OBT by Smithkline Diagnostics, Inc.
- EASE-A-CULT by Diagnostica, Inc.
- IMMUNOCCULT EIA TEST KIT by Intl. Immunoassay Laboratories, Inc.
- HEMOCCULT-C by Menley & James Laboratories
- FLEET DETECTATEST by C.B. Fleet Co., Inc.
- OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT by Sekisui Diagnostics, LLC