# K961337: Exactech RSG Blood Glucose Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Medisense, Inc.
- Decided: Jun 21, 1996 after 74 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 K863468 (1986). 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)
- K863468: Exactech (TM), Travenol Laboratories, S.A. (1986) Summary page 1.

## Indications for use
The ExacTech RSG Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The product is designed for home or professional use.

Source page: https://510kreport.com/device/K961337
Methodology: https://510kreport.com/methodology