# K965103: Winmax Software Systems

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: May 9, 1997 after 140 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- 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 no predicate by number.

## Indications for use
DPC's WinMAX software system is a comprehensive software program for processing DPC's in vitro diagnostic assays. the AlaSTAT and AlaTOP immunodiagnostic allergy test kits, in the microtiter plate format It is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K965103
Methodology: https://510kreport.com/methodology