ACE Axcel® 404200-1
ACE Axcel® 404200-1 is a Class I device made by Alfa Wassermann, Inc., cleared under FDA 510(k) K113253 on 17 May 2012 and listed in FDA GUDID since 7 Jan 2021 (UDI-DI 00857969006709), 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 | Number00857969006709 | Date7 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113253 | Date17 May 2012 | StatusActive |
Official records
- AccessGUDID record 00857969006709
- FDA 510(k) database K113253
Across registries
- FDA 510(k) K113253 decided 17 May 2012 Active
- FDA GUDID UDI-DI 00857969006709 listed 7 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K113253
- Listed FDA GUDID 00857969006709
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ACE Axcel®
- Generic name
- Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
- Model / Ref / Catalog
- 404200-1
- Primary DI / UDI-DI
- 00857969006709
- 510(k) Number
- FDA product code
- JJE
- GMDN term
- Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
- Device class
- Class I
- Regulation number
- 862.2160
- GUDID distribution status
- In Commercial Distribution
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