Ace SA1017
Ace SA1017 is a Class I device made by Alfa Wassermann, Inc., cleared under FDA 510(k) K113438 on 1 Jun 2012 and listed in FDA GUDID since 10 Oct 2017 (UDI-DI 00857969006495), 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 | Number00857969006495 | Date10 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113438 | Date1 Jun 2012 | StatusActive |
Official records
- AccessGUDID record 00857969006495
- FDA 510(k) database K113438
Across registries
- FDA 510(k) K113438 decided 1 Jun 2012 Active
- FDA GUDID UDI-DI 00857969006495 listed 10 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K113438
- Listed FDA GUDID 00857969006495
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ace
- Generic name
- Iron IVD, reagent
- Model / Ref / Catalog
- SA1017
- Primary DI / UDI-DI
- 00857969006495
- 510(k) Number
- FDA product code
- JIY
- GMDN term
- Iron IVD, reagent
- Device class
- Class I
- Regulation number
- 862.1410
- GUDID distribution status
- In Commercial Distribution
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