Dealmed 788525
by Dealmed Medical Supplies LLC
Dealmed 788525 is a Class II device made by Dealmed Medical Supplies LLC, cleared under FDA 510(k) K043443 on 8 Apr 2005 and listed in FDA GUDID since 11 Jun 2021 (UDI-DI 00817415021069), 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 | Number00817415021069 | Date11 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043443 | Date8 Apr 2005 | StatusActive |
Official records
- AccessGUDID record 00817415021069
- FDA 510(k) database K043443
Across registries
- FDA 510(k) K043443 decided 8 Apr 2005 Active
- FDA GUDID UDI-DI 00817415021069 listed 11 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K043443
- Listed FDA GUDID 00817415021069
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dealmed
- Generic name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- 788525
- Primary DI / UDI-DI
- 00817415021069
- 510(k) Number
- FDA product code
- JHI, LCX
- GMDN term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.1155
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical.