Immco Diagnostics 2189
Immco Diagnostics 2189 is a Class II device made by Immco Diagnostics, Inc., cleared under FDA 510(k) K982898 on 30 Nov 1998 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714003370), 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 | Number00845714003370 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK982898 | Date30 Nov 1998 | StatusActive |
Official records
- AccessGUDID record 00845714003370
- FDA 510(k) database K982898
Across registries
- FDA 510(k) K982898 decided 30 Nov 1998 Active
- FDA GUDID UDI-DI 00845714003370 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K982898
- Listed FDA GUDID 00845714003370
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Immco Diagnostics
- Generic name
- General specimen microscopy slide IVD, single-use
- Model / Ref / Catalog
- 2189
- Primary DI / UDI-DI
- 00845714003370
- 510(k) Number
- FDA product code
- MOB
- GMDN term
- General specimen microscopy slide IVD, single-use
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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