# K973335: Quatro SP Sample Processing Systems (200-499, Inclusive)

- Pathway: 510(k) (Traditional)
- Applicant: Zenyx Scientific, Ltd.
- Decided: Apr 30, 1998 after 238 days
- Product code: JQW (Station, Pipetting And Diluting, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2750
- 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 K800775 (1980). 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)
- K800775: Aldoctk-125, Sorin Biomedica, Fiat, USA, Inc. (1980) Summary page 1.

## Indications for use
The Quatro SP Series Robotic Sample Processing Systems and their accessories are provided as generic liquid handling systems which must be customized and validated for each user environment, according to in vitro diagnostic test instructions and requirements. The customization can be accomplished by users or can be provided, to customer specifications, by Zenyx authorized representatives.

Source page: https://510kreport.com/device/K973335
Methodology: https://510kreport.com/methodology