Henry Schein 5700609
Henry Schein 5700609 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 10304040054175), 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 | Number10304040054175 | Date14 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143325 | Date20 Aug 2015 | StatusActive |
Official records
- AccessGUDID record 10304040054175
- FDA 510(k) database K143325
Across registries
- FDA 510(k) K143325 decided 20 Aug 2015 Active
- FDA GUDID UDI-DI 10304040054175 listed 14 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K143325
- Listed FDA GUDID 10304040054175
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- Withdrawn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
- 5700609
- Primary DI / UDI-DI
- 10304040054175
- 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).
- UROPAPER EIKEG by Syn-Kit, Inc.
- BIOTEL (TM)/ KIDNEY by American Diagnostic Corporation
- HELENA COLOSCREEN by Helena Laboratories, Corp.
- DBEST ONE STEP OCCULT BLOOD TEST KITS by AMERITEKUSA, INC.
- REVISED IMMUDIA HEM-SP by Schiff & Co.
- ACCESS DIGIWIPE SYSTEM by MEDTECH PRODUCTS, INC.
- FE-CULT PLUS by Gamma Biologicals, Inc.
- COLOCARE by Helena Laboratories, Corp.
- IND ONE STEP OCCULT BLOOD (FOB) TEST by Ind Diagnostics, Inc.
- RESUBMITTED FECATWIN SENSITIVE - FECA-EIA by Labsystems, Inc.