# K963541: Sigma Diagnostics CO2 Acid Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Oct 24, 1996 after 50 days
- Product code: JFL (Ph Rate Measurement, 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. The FDA summary names its predicate without a number.
- (no number) Beckman CO₂ Acid Reagent Kit, Part No. 443330: named in the summary without a submission number

## Indications for use
Both CO₂ acid reagents are used to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX®3 System.

Source page: https://510kreport.com/device/K963541
Methodology: https://510kreport.com/methodology