# K924244: Roche Reagent for Ast

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Jan 4, 1993 after 133 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K080485: Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FS (2008), 0 descendants of its own
- K981225: Aspartate Aminotransferase (Ast) (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K924244
Methodology: https://510kreport.com/methodology