ASA2 Hemo Control 5329
ASA2 Hemo Control 5329 is a Class II device made by Helena Laboratories, Corp., cleared under FDA 510(k) K800853 on 29 Apr 1980 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI M52553290), 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 | NumberM52553290 | Date7 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK800853 | Date29 Apr 1980 | StatusActive |
Official records
- FDA 510(k) database K800853
Across registries
- FDA 510(k) K800853 decided 29 Apr 1980 Active
- FDA GUDID UDI-DI M52553290 listed 7 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K800853
- Listed FDA GUDID M52553290
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ASA2 Hemo Control
- Generic name
- Inherited haemoglobinopathy IVD, control
- Model / reference
- 5329
- Primary DI / UDI-DI
- M52553290
- 510(k) Number
- FDA product code
- JBD
- GMDN term
- Inherited haemoglobinopathy IVD, control
- Device class
- Class II
- Regulation number
- 864.7440
- GUDID distribution status
- In Commercial Distribution
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