HemoCue Hb 801 System
K-Number: K181751 · 2019-02-01
ApplicantHemocue AB
Decision Date2019-02-01
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemoCue Hb 801 System is a medical device manufactured by Hemocue AB. It received FDA 510(k) clearance on 2019-02-01 under approval number K181751. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemoCue Hb 801 System?
HemoCue Hb 801 System is a medical device that received FDA 510(k) clearance on 2019-02-01. It is manufactured by Hemocue AB. The 510(k) number is K181751.
When was HemoCue Hb 801 System approved by the FDA?
HemoCue Hb 801 System received FDA 510(k) clearance on 2019-02-01, under approval number K181751.
What company makes HemoCue Hb 801 System?
HemoCue Hb 801 System is manufactured by Hemocue AB.
What is the FDA product code for HemoCue Hb 801 System?
The FDA product code for HemoCue Hb 801 System is GKR.
Other Devices by Hemocue AB
Related Devices (Code: GKR)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.