JAS Diagnostics ALBS-3
JAS Diagnostics ALBS-3 is a Class II device made by Drew Scientific, Ltd., cleared under FDA 510(k) K822471 on 14 Sep 1982 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00817274020661), 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 | Number00817274020661 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK822471 | Date14 Sep 1982 | StatusActive |
Official records
- AccessGUDID record 00817274020661
- FDA 510(k) database K822471
Across registries
- FDA 510(k) K822471 decided 14 Sep 1982 Active
- FDA GUDID UDI-DI 00817274020661 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K822471
- Listed FDA GUDID 00817274020661
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- JAS Diagnostics
- Generic name
- Afamin IVD, kit, nephelometry/turbidimetry
- Model / reference
- ALBS-3
- Primary DI / UDI-DI
- 00817274020661
- 510(k) Number
- FDA product code
- CIX
- GMDN term
- Afamin IVD, kit, nephelometry/turbidimetry
- Device class
- Class II
- Regulation number
- 862.1035
- GUDID distribution status
- In Commercial Distribution
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