AST
by Gilford Diagnostics 510(k)
Active
510(k) K781784
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781784 | Date3 Jan 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1100
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
AST is a clinical chemistry device used for the measurement of NADH oxidation/NAD reduction, also known as AST/SGOT. It is classified as a Class II medical device in the field of clinical chemistry.
The device is manufactured by Gilford Diagnostics and was FDA 510(k) cleared on January 3, 1979 under product code CIT. It is supplied with various registration numbers and is intended for use in clinical laboratory settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.