Spotcheck 80-3000-13K
Spotcheck 80-3000-13K is a Class II device made by Astoria-Pacific, Inc., cleared under FDA 510(k) K990957 on 11 May 1999 and listed in FDA GUDID since 14 Oct 2016 (UDI-DI 00725609000021), 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 | Number00725609000021 | Date14 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK990957 | Date11 May 1999 | StatusActive |
Official records
- AccessGUDID record 00725609000021
- FDA 510(k) database K990957
Across registries
- FDA 510(k) K990957 decided 11 May 1999 Active
- FDA GUDID UDI-DI 00725609000021 listed 14 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K990957
- Listed FDA GUDID 00725609000021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spotcheck
- Generic name
- Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence
- Model / Ref / Catalog
- 80-3000-13K
- Primary DI / UDI-DI
- 00725609000021
- 510(k) Number
- FDA product code
- JBL
- GMDN term
- Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence
- Device class
- Class II
- Regulation number
- 864.7360
- GUDID distribution status
- In Commercial Distribution