# K801295: Cobas Reagent for a-Amylase

- Pathway: 510(k) (Traditional)
- Applicant: Roche Analytical Instruments, Inc.
- Decided: Jul 8, 1980 after 36 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K062180: Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CP (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K801295
Methodology: https://510kreport.com/methodology