# K991108: Carbon Dioxide (CO2), Product NO. CC0107-01

- Pathway: 510(k) (Traditional)
- Applicant: A.P. Total Care, Inc.
- Decided: May 25, 1999 after 54 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
The carbon dioxide reagent (CO2), product No. C0107-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of CO2 in serum or plasma.

Source page: https://510kreport.com/device/K991108
Methodology: https://510kreport.com/methodology