Diamedix 720-430
Diamedix 720-430 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K012450 on 26 Oct 2001 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020242), 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 | Number00817273020242 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012450 | Date26 Oct 2001 | StatusActive |
Official records
- AccessGUDID record 00817273020242
- FDA 510(k) database K012450
Across registries
- FDA 510(k) K012450 decided 26 Oct 2001 Active
- FDA GUDID UDI-DI 00817273020242 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K012450
- Listed FDA GUDID 00817273020242
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- Withdrawn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
- 720-430
- Description
- "720-430 anti-MPO (P-ANCA) IgG Test Kit"
- Primary DI / UDI-DI
- 00817273020242
- 510(k) Number
- FDA product code
- MID
- GMDN term
- Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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- HEMAGEN ANTI CARDIOLIPIN SCREEN by HEMAGEN DIAGNOSTICS, INC.
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