Quantra Hemostasis Analyzer
K-Number: K232215 · 2023-08-24
ApplicantHemosonics, LLC
Decision Date2023-08-24
Product CodeQFR
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Quantra Hemostasis Analyzer is a medical device manufactured by Hemosonics, LLC. It received FDA 510(k) clearance on 2023-08-24 under approval number K232215. The device is classified under product code QFR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Quantra Hemostasis Analyzer?
Quantra Hemostasis Analyzer is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Hemosonics, LLC. The 510(k) number is K232215.
When was Quantra Hemostasis Analyzer approved by the FDA?
Quantra Hemostasis Analyzer received FDA 510(k) clearance on 2023-08-24, under approval number K232215.
What company makes Quantra Hemostasis Analyzer?
Quantra Hemostasis Analyzer is manufactured by Hemosonics, LLC.
What is the FDA product code for Quantra Hemostasis Analyzer?
The FDA product code for Quantra Hemostasis Analyzer is QFR.
Related Clinical Trials
Other Devices by Hemosonics, LLC
Related Devices (Code: QFR)
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.