# K923505: Ast (Got) - Aspartate Aminotransferase

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Nov 16, 1992 after 124 days
- Product code: CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot)
- Device class: 2
- Regulation: 21 CFR 862.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K131554: RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast) Reagent (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K923505
Methodology: https://510kreport.com/methodology