Alfa Wassermann S2-87
Alfa Wassermann S2-87 is a Class II device made by Alfa Wassermann, Inc., cleared under FDA 510(k) K063306 on 17 Apr 2007 and listed in FDA GUDID since 3 Apr 2020 (UDI-DI 00857969006600), 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 | Number00857969006600 | Date3 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK063306 | Date17 Apr 2007 | StatusActive |
Official records
- AccessGUDID record 00857969006600
- FDA 510(k) database K063306
Across registries
- FDA 510(k) K063306 decided 17 Apr 2007 Active
- FDA GUDID UDI-DI 00857969006600 listed 3 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K063306
- Listed FDA GUDID 00857969006600
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alfa Wassermann
- Generic name
- Glycated haemoglobin (HbA1c) IVD, calibrator
- Model / Ref / Catalog
- S2-87
- Primary DI / UDI-DI
- 00857969006600
- 510(k) Number
- FDA product code
- JIS
- GMDN term
- Glycated haemoglobin (HbA1c) IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
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