# K070251: Carbon Dioxide Liquid Stable Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Apr 30, 2007 after 94 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K170200: Carbon Dioxide Reagent Set (2017), 0 descendants of its own

## Indications for use
This product is to be used for the quantitative determination of carbon dioxide in human serum by spectrophotometric analysis. The determination of the level of carbon dioxide in serum is commonly performed as an indicator of acid-base balance disturbances.

Source page: https://510kreport.com/device/K070251
Methodology: https://510kreport.com/methodology