# K994073: Hemosite Test System

- Pathway: 510(k) (Traditional)
- Applicant: Gds Technology, LLC
- Decided: Jan 14, 2000 after 43 days
- Product code: KHG (Whole Blood Hemoglobin Determination)
- Device class: 2
- Regulation: 21 CFR 864.7500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896873 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973649: Hemosite Test System, Gds Technology, LLC (1998) Summary page 2.

## Indications for use
The HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter.

Source page: https://510kreport.com/device/K994073
Methodology: https://510kreport.com/methodology