Diamedix 720-460
Diamedix 720-460 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K984228 on 2 Feb 1999 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020273), 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 | Number00817273020273 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK984228 | Date2 Feb 1999 | StatusActive |
Official records
- AccessGUDID record 00817273020273
- FDA 510(k) database K984228
Across registries
- FDA 510(k) K984228 decided 2 Feb 1999 Active
- FDA GUDID UDI-DI 00817273020273 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K984228
- Listed FDA GUDID 00817273020273
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamedix
- Generic name
- Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- 720-460
- Description
- "720-460 anti-TG IgG Test Kit"
- Primary DI / UDI-DI
- 00817273020273
- 510(k) Number
- FDA product code
- JZO
- GMDN term
- Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.5870
- GUDID distribution status
- In Commercial Distribution
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