# K974000: Y-Glutamyltransferase-SL  Assay , Cataloge Number 324-10, 324-30

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Nov 4, 1997 after 14 days
- Product code: JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase)
- Device class: 1
- Regulation: 21 CFR 862.1360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For the quantitative determination of A-GT in serum. For IN VITRO diagnostic use.

Source page: https://510kreport.com/device/K974000
Methodology: https://510kreport.com/methodology