Pointe Scientific, Inc. HA902-2000
by Horiba Instruments Incorporated
Pointe Scientific, Inc. HA902-2000 is a Class II device made by Horiba Instruments Incorporated, cleared under FDA 510(k) K822471 on 14 Sep 1982 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00811727014634), active as of 24 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 | Number00811727014634 | Date31 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK822471 | Date14 Sep 1982 | StatusActive |
Official records
- AccessGUDID record 00811727014634
- FDA 510(k) database K822471
Across registries
- FDA 510(k) K822471 decided 14 Sep 1982 Active
- FDA GUDID UDI-DI 00811727014634 listed 31 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K822471
- Listed FDA GUDID 00811727014634
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pointe Scientific, Inc.
- Generic name
- Albumin IVD, kit, spectrophotometry
- Model / Ref / Catalog
- HA902-2000
- Primary DI / UDI-DI
- 00811727014634
- 510(k) Number
- FDA product code
- CIX
- GMDN term
- Albumin IVD, kit, spectrophotometry
- Device class
- Class II
- Regulation number
- 862.1035
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Albumin IVD, kit, spectrophotometry.