# K953211: Amylase (Ethylidene PNGPG7) Kit

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jun 21, 1996 after 347 days
- Product code: CIJ (Saccharogenic, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- Recalls of this device: 1 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jul 10, 2020 · Class II · Z-2923-2020: Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

Source page: https://510kreport.com/device/K953211
Methodology: https://510kreport.com/methodology