QStat Cartridge
K-Number: K213917 · 2022-11-29
Device Summary
Frequently Asked Questions
What is the QStat Cartridge?
QStat Cartridge is a medical device that received FDA 510(k) clearance on 2022-11-29. The listed applicant is Hemosonics, LLC. The 510(k) number is K213917.
When did QStat Cartridge receive FDA 510(k) clearance?
QStat Cartridge received FDA 510(k) clearance on 2022-11-29, under 510(k) number K213917.
Who is the listed applicant for 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 QStat Cartridge?
The FDA product code for 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.