# K060765: Hemocue Glucose 201 RT Analyzer MDL 120731, Hemocue Glucose 201 RT Microcurettes MDL 110712

- Pathway: 510(k) (Traditional)
- Applicant: Hemocue AB
- Decided: Sep 6, 2006 after 169 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
Longest line of descent: 1 generation back to K020935 (2002). 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)
- K020935: Hemocue Glucose 201 System, Article Number 120706, Hemocue, Inc. (2002) Summary page 1.

## Indications for use
The HemoCue Glucose 201 RT system is used for quantitative determination of glucose in whole blood supplementing the clinical evidence in the diagnosis and treatment of patients with diabetes. The HemoCue Glucose 201 RT system is for In Vitro Diagnostic use only. The HemoCue Glucose 201 RT Analyzer is only to be used with HemoCue Glucose 201 RT Microcuvettes. For professional use only.

Source page: https://510kreport.com/device/K060765
Methodology: https://510kreport.com/methodology