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510(k) K240315

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) by Siemens Healthcare Diagnostics Products GmbH — Product Code QLU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2024
Date Received
February 2, 2024
Clearance Type
Traditional
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.

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