Quantra QStat Cartridge
K-Number: K251404 · 2025-08-25
Device Summary
Frequently Asked Questions
What is the Quantra QStat Cartridge?
Quantra QStat Cartridge is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Hemosonics, LLC. The 510(k) number is K251404.
When did Quantra QStat Cartridge receive FDA 510(k) clearance?
Quantra QStat Cartridge received FDA 510(k) clearance on 2025-08-25, under 510(k) number K251404.
Who is the listed applicant for Quantra QStat Cartridge?
The FDA 510(k) record lists Hemosonics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Quantra QStat Cartridge?
The FDA product code for Quantra QStat Cartridge is QFR.
Other records listing Hemosonics, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QFR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.