# K980902: N-Assay L Ast/Got

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: Mar 26, 1998 after 16 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
Longest line of descent: 1 generation back to K861792 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861792: Twin Got-Ast Ifcc/GPT-Alt Ifcc, Boehringer Mannheim Corp. (1986) Summary page 2.

## Indications for use
The intended use for the N-ASSAY L AST/GOT Reagent is for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum in the diagnosis and treatment of certain types of liver, heart, and muscle diseases. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K980902
Methodology: https://510kreport.com/methodology