# K980056: Careside Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Exigent Diagnostics, Inc.
- Decided: Mar 6, 1998 after 59 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- 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 K912844 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 1.

## Most influential descendants
- K993634: Careside Analyzer (1999), 0 descendants of its own

## Indications for use
For in vitro diagnostic use by professionals with Exigent Diagnostics Cartridges for the in vitro measurement of various clinical chemistry analytes in human blood.

Source page: https://510kreport.com/device/K980056
Methodology: https://510kreport.com/methodology