# K801118: Cobas Reagent for Ast (Sgot)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Analytical Instruments, Inc.
- Decided: Jun 20, 1980 after 39 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K060318: Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer (2006), 2 descendants of its own
- K102647: Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1 SL/Potassium, Sodium, Chloride... (2011), 0 descendants of its own
- K093883: Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250, Assl-0455, Cali-0580, Cont-0080, Cont- (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K801118
Methodology: https://510kreport.com/methodology