# K964715: Paramax Salicylate Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Apr 25, 1997 after 151 days
- Product code: DKJ (Colorimetry, Salicylate)
- Device class: 2
- Regulation: 21 CFR 862.3830
- 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 K771805 (1977). 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)
- K771805: Aca Salicylate Calibrator, E.I. Dupont DE Nemours & Co., Inc. (1977) Summary page 1.

## Indications for use
The proposed and the predicate device are intended for use as quantitative determination of salicylate in plasma and serum.

Source page: https://510kreport.com/device/K964715
Methodology: https://510kreport.com/methodology