Immco Diagnostics 2216
Immco Diagnostics 2216 is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K891098 on 22 Mar 1989 (1 earlier submission) and listed in FDA GUDID since 16 Nov 2016 (UDI-DI 00845714003707), 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 | Number00845714003707 | Date16 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK891098 | Date22 Mar 1989 | StatusActive |
Official records
- AccessGUDID record 00845714003707
- FDA 510(k) database K891098
- FDA 510(k) database K891099
Across registries
- FDA 510(k) K891098 decided 22 Mar 1989 Active
- FDA GUDID UDI-DI 00845714003707 listed 16 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K891098
- Cleared FDA 510(k) K891099
- Listed FDA GUDID 00845714003707
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Immco Diagnostics
- Generic name
- Skin antibody IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 2216
- Primary DI / UDI-DI
- 00845714003707
- FDA product code
- DBL
- GMDN term
- Skin antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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