ACE Elevated Control SC-131EL
ACE Elevated Control SC-131EL is a Class I device made by Analytical Control Systems, cleared under FDA 510(k) K940272 on 20 Apr 1994 and listed in FDA GUDID since 31 Jan 2019 (UDI-DI 00817869020298), 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 | Number00817869020298 | Date31 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK940272 | Date20 Apr 1994 | StatusActive |
Official records
- AccessGUDID record 00817869020298
- FDA 510(k) database K940272
Across registries
- FDA 510(k) K940272 decided 20 Apr 1994 Active
- FDA GUDID UDI-DI 00817869020298 listed 31 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K940272
- Listed FDA GUDID 00817869020298
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ACE Elevated Control
- Generic name
- Angiotensin converting enzyme (ACE) IVD, control
- Model / Ref / Catalog
- SC-131EL
- Primary DI / UDI-DI
- 00817869020298
- 510(k) Number
- FDA product code
- JJX
- GMDN term
- Angiotensin converting enzyme (ACE) IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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