# K962231: Cobas Core Immunochemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Aug 30, 1996 after 81 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921180 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921180: Cobas Core Immunochemistry System, Roche Diagnostic Systems, Inc. (1992) Summary page 1.

## Indications for use
The COBAS Core II Immunochemistry System is an in vitro diagnostic analyzer intended for enzymeimmunoassay procedures. The instrument performs initial sample measurement and pipetting, timed addition of assay reagents, incubation and shaking of assay tubes, aspiration of used reagents and washing of coated polystyrene assay beads and photometric measurement of the chromogen / enzyme reaction.

Source page: https://510kreport.com/device/K962231
Methodology: https://510kreport.com/methodology