C. Diff Quik Chek Complete 30550C
C. Diff Quik Chek Complete 30550C is a Class I device made by Techlab, Inc., cleared under FDA 510(k) K082499 on 26 Mar 2009 and listed in FDA GUDID since 7 Aug 2018 (UDI-DI 00857031002387), 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 | Number00857031002387 | Date7 Aug 2018 | StatusListed |
| United States | FDA 510(k) | NumberK082499 | Date26 Mar 2009 | StatusActive |
Official records
- AccessGUDID record 00857031002387
- FDA 510(k) database K082499
Across registries
- FDA 510(k) K082499 decided 26 Mar 2009 Active
- FDA GUDID UDI-DI 00857031002387 listed 7 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K082499
- Listed FDA GUDID 00857031002387
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- C. Diff Quik Chek Complete
- Generic name
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
- Model / reference
- 30550C
- Primary DI / UDI-DI
- 00857031002387
- 510(k) Number
- FDA product code
- LLH
- GMDN term
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class I
- Regulation number
- 866.2660
- GUDID distribution status
- In Commercial Distribution