HemoCue Hb 301 System
K-Number: K201217 · 2020-08-04
ApplicantHemocue AB
Decision Date2020-08-04
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemoCue Hb 301 System is a medical device manufactured by Hemocue AB. It received FDA 510(k) clearance on 2020-08-04 under approval number K201217. 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 301 System?
HemoCue Hb 301 System is a medical device that received FDA 510(k) clearance on 2020-08-04. It is manufactured by Hemocue AB. The 510(k) number is K201217.
When was HemoCue Hb 301 System approved by the FDA?
HemoCue Hb 301 System received FDA 510(k) clearance on 2020-08-04, under approval number K201217.
What company makes HemoCue Hb 301 System?
HemoCue Hb 301 System is manufactured by Hemocue AB.
What is the FDA product code for HemoCue Hb 301 System?
The FDA product code for HemoCue Hb 301 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.