510(k) DEN190032
DEN190032 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HemosIL Liquid Anti-Xa". The FDA issued a decision of De Novo Granted on September 17, 2020. The device falls under product code QLU (Anti-Factor Xa Activity Test System, Apixaban), a Class II device regulated under 21 CFR 864.7295. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 17, 2020
- Date Received
- June 25, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Factor Xa Activity Test System, Apixaban
- Device Class
- Class II
- Regulation Number
- 864.7295
- Review Panel
- HE
- Submission Type
A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.