Immco Diagnostics 2250g
Immco Diagnostics 2250g is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K060157 on 25 May 2006 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714003967), 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 | Number00845714003967 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK060157 | Date25 May 2006 | StatusActive |
Official records
- AccessGUDID record 00845714003967
- FDA 510(k) database K060157
Across registries
- FDA 510(k) K060157 decided 25 May 2006 Active
- FDA GUDID UDI-DI 00845714003967 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K060157
- Listed FDA GUDID 00845714003967
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Immco Diagnostics
- Generic name
- Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 2250G
- Primary DI / UDI-DI
- 00845714003967
- 510(k) Number
- FDA product code
- MVM
- GMDN term
- Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay.
- Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12080-01 by IMMUNO CONCEPTS INC
- IFA: Oesophagus (Monkey) IgA EUROPattern FC 1911-1010 A by EUROIMMUN Medizinische Labordiagnostika AG
- Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12040-01 by IMMUNO CONCEPTS INC
- IFA: Oesophagus (Monkey) IgA FA 1911-1005 A by EUROIMMUN Medizinische Labordiagnostika AG