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FDA 510(k) Clearance and Launch in US

We are happy to announce that on February 1, 2019, we received USFDA 510(k) clearance from the US Food and Drug Administration for our HemoCue Hb 801 System. With the USFDA 510(k) clearance the product is now also launched on the US market.

February 20, 2019

On February 1, 2019, we received US Food and Drug Administration (USFDA) 510(k) clearance of our latest point-of-care hemoglobin test, the HemoCue® Hb 801 System.

The product was CE-marked in June 2018 and beginning of January 2019 launched in a number of countries in Europe, South America, Africa and Asia Pacific. With the USFDA 510(k) clearance we are now very pleased to introduce our new system on the US market as well.

"HemoCue is a pioneer in point-of-care testing. The innovative HemoCue® Hb 801 provides ease of use and enables workflow efficiency with connectivity capabilities delivering fast results at the time of care." 

"Our tests make it it easy for clinicians to get a lab-quality result while the patient is still present, which allows for more engagement in the overall healthcare process."
says Christophe Duret, president of HemoCue AB.  


 USFDA 510k and US launch for news section


Hemoglobin testing helps clinicians to detect anemia, a condition in which the body lacks enough healthy red blood cells, or hemoglobin. Anemia, in most cases, is very treatable. 

The HemoCue® Hb 801 System quantitatively measures hemoglobin in capillary or venous whole blood, and is for professional in vitro diagnostic use only. 

The HemoCue® Hb 801 System is intended to be used to determine the hemoglobin concentrations for adults, adolescents, children, and infants above 1 month old. The system, which is CLIA-waived, consists of an analyzer together with microcuvettes. 

Read more about the system here

* K181751; FDA cleared on February 1, 2019

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