# K991870: Electrolytes (NA+, K+, CL-), Product No's 114-01, 114-02, 114-03

- Pathway: 510(k) (Traditional)
- Applicant: A.P. Total Care, Inc.
- Decided: Jul 30, 1999 after 59 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- 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 ISE Electrolyte (Na+, K+ and Cl-) reagents, product No. 114-01, 1114-02 and 114-03 are intended for Invitro Diagnostic use in the automated, quantitative determination of sodium, potassium and chloride in serum, or plasma.

Source page: https://510kreport.com/device/K991870
Methodology: https://510kreport.com/methodology