# K903309: Roche Cobas Ready Amylase Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Sep 7, 1990 after 45 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K191454: Atellica CH Amylase_2 (AMY_2) (2019), 0 descendants of its own
- K981216: AMY (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K903309
Methodology: https://510kreport.com/methodology