FDA.reportPublic FDA data

510(k) K240315

Device
INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
Applicant
Siemens Healthcare Diagnostics Products GmbH
510(k) number
K240315
Product code
QLU
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-10
Date received
2024-02-02
Regulation
864.7295
Classification name
Anti-Factor Xa Activity Test System, Apixaban
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anja Wilhelm
Address
Emil-Von-Behring-Strasse 76 Marburg DE 35041 35041

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QLU#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO2023-06-23
DEN190032HemosIL Liquid Anti-XaInstrumentation Laboratory CO2020-09-17