# K061047: Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801

- Pathway: 510(k) (Traditional)
- Applicant: Hemocue AB
- Decided: Jun 8, 2006 after 55 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- 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 K032203 (2003). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032203: Hemocue Hemoglobin 201 + System Article 121704, Hemocue, Inc. (2003) Summary page 1.

## Most influential descendants
- K181751: HemoCue Hb 801 System (2019), 1 descendant of its own
- K201217: HemoCue Hb 301 System (2020), 0 descendants of its own
- K182298: hemochroma PLUS System (2018), 0 descendants of its own
- K163465: hemochroma PLUS System (2017), 0 descendants of its own

## Indications for use
The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.

Source page: https://510kreport.com/device/K061047
Methodology: https://510kreport.com/methodology