Immunoassay Control Level 3 94103
Immunoassay Control Level 3 94103 is a Class I device made by Cliniqa Corporation, cleared under FDA 510(k) K083554 on 21 Apr 2009 and listed in FDA GUDID since 22 Aug 2018 (UDI-DI 00817238010424), active as of 8 Nov 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 | Number00817238010424 | Date22 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083554 | Date21 Apr 2009 | StatusActive |
Official records
- AccessGUDID record 00817238010424
- FDA 510(k) database K083554
Across registries
- FDA 510(k) K083554 decided 21 Apr 2009 Active
- FDA GUDID UDI-DI 00817238010424 listed 22 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K083554
- Listed FDA GUDID 00817238010424
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Immunoassay Control Level 3
- Generic name
- Multiple-type clinical chemistry analyte profile IVD, control
- Model / reference
- 94103
- Primary DI / UDI-DI
- 00817238010424
- 510(k) Number
- FDA product code
- JJY
- GMDN term
- Multiple-type clinical chemistry analyte profile IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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