# K170200: Carbon Dioxide Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics, Inc.
- Decided: Jun 1, 2017 after 129 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 K070251 (2007). 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)
- K070251: Carbon Dioxide Liquid Stable Reagent, Pointe Scientific, Inc., (2007) Summary page 6.

## Indications for use
Teco Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis.

Source page: https://510kreport.com/device/K170200
Methodology: https://510kreport.com/methodology