Ast(Got) (Aspartate Aminotransferase) Reagent
by Trace Scientific, Ltd. 2 variants
510(k) K864357
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864357 | Date6 Feb 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CIT
- FDA applicant
- Trace Scientific , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1100
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Ast(Got) (Aspartate Aminotransferase) Reagent is a device used in clinical chemistry for Nadh oxidation/nad reduction, Ast/sgot. It is classified as a Class II device with special controls.
The device is supplied by Trace Scientific, Ltd. and has been found to be substantially equivalent. It is regulated under regulation number 862.1100 and has a product code of CIT. The device has an FDA 510(k) clearance, K864357.
Other devices from Trace Scientific, Ltd.
Questions
AI-generated answers, 26 Sep 2026
What is the Ast(Got) Reagent used for?
The Ast(Got) Reagent is used in clinical chemistry for Nadh oxidation/nad reduction, Ast/sgot, which is a diagnostic test.
Who is the manufacturer of the Ast(Got) Reagent?
The Ast(Got) Reagent is manufactured by Trace Scientific, Ltd.
What is the regulatory classification of the Ast(Got) Reagent?
The Ast(Got) Reagent is classified as a Class II device with special controls, regulated under regulation number 862.1100.