# K972876: Glucotrend Basic System

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 9, 1997 after 66 days
- Product code: LFR (Glucose Dehydrogenase, 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
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 its predicate without a number.
- (no number) Boehringer Mannheim Accu-Chek Advantage System with the Advantage H Test Strip: named in the summary without a submission number

## Indications for use
The Glucotrend Basic System is designed for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.

Source page: https://510kreport.com/device/K972876
Methodology: https://510kreport.com/methodology