# K993634: Careside Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Dec 2, 1999 after 36 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: 2 generations back to K912844 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
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 2.
- K980056: Careside Analyzer, Exigent Diagnostics, Inc. (1998) Summary page 2.

## Indications for use
The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in whole blood, plasma, and serum. It is intended for in vitro diagnostic use and is intended for point of care use.

Source page: https://510kreport.com/device/K993634
Methodology: https://510kreport.com/methodology