# K012332: Jas Carbon Dioxide Liquid Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Jas Diagnostics, Inc.
- Decided: Sep 6, 2001 after 45 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intended for the In Vitro, quantitative determination of carbon dioxide in human serum on automated chemistry analyzers. Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Source page: https://510kreport.com/device/K012332
Methodology: https://510kreport.com/methodology