# K844987: Roche Reagents Reagent for CO2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Jan 18, 1985 after 23 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992140: Piccolo Metlyte 7 Reagent Disc (1999), 1 descendant of its own
- K200865: Piccolo Potassium Test System (2021), 0 descendants of its own
- K981231: CO2 (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K844987
Methodology: https://510kreport.com/methodology