ACE Calibrator SC-132
ACE Calibrator SC-132 is a Class II device made by Analytical Control Systems, cleared under FDA 510(k) K930477 on 7 Jun 1993 and listed in FDA GUDID since 31 Jan 2019 (UDI-DI 00817869020304), 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 | Number00817869020304 | Date31 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK930477 | Date7 Jun 1993 | StatusActive |
Official records
- AccessGUDID record 00817869020304
- FDA 510(k) database K930477
Across registries
- FDA 510(k) K930477 decided 7 Jun 1993 Active
- FDA GUDID UDI-DI 00817869020304 listed 31 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K930477
- Listed FDA GUDID 00817869020304
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ACE Calibrator
- Generic name
- Angiotensin converting enzyme (ACE) IVD, calibrator
- Model / Ref / Catalog
- SC-132
- Primary DI / UDI-DI
- 00817869020304
- 510(k) Number
- FDA product code
- JIS
- GMDN term
- Angiotensin converting enzyme (ACE) IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution