# K982056: Raichem CO2 Reagent

- Pathway: 510(k) (Special)
- Applicant: Reagents Applications, Inc.
- Decided: Jun 24, 1998 after 15 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
Longest line of descent: 1 generation back to K854544 (1985). 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)
- K854544: Raichem CO2 Reagent, Reagents Applications, Inc. (1985) Summary page 1.

## Indications for use
The use of this reagent is indicated for the measurement of CO2 levels in serum or plasma on manual or automated systems. The measurement of serum or plasma CO2 content is useful in the assessment of disturbance of acid base balance in respiratory or metabolic acidosis and alkalosis

Source page: https://510kreport.com/device/K982056
Methodology: https://510kreport.com/methodology