# K963540: Sigma Diagnostics Electrolyte Buffer

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Sep 27, 1996 after 23 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 Electrolyte Buffer Kit: named in the summary without a submission number

## Indications for use
Both electrolyte buffers are used to measure sodium, chloride, potassium, and carbon dioxide concentrations in serum or plasma, sodium, potassium, and chloride concentrations in urine, and chloride concentrations in CSF on the SYNCHRON CX®3 System

Source page: https://510kreport.com/device/K963540
Methodology: https://510kreport.com/methodology