# K040920: Amylase Liquid Reagent, Model A532-200

- Pathway: 510(k) (Special)
- Applicant: Teco Diagnostics
- Decided: May 10, 2004 after 32 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- 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 Amylase in human serum and urine. Amylase measurements are used primarily for the diagnostics and treatment of pancreatitis.

Source page: https://510kreport.com/device/K040920
Methodology: https://510kreport.com/methodology