FDA.reportPublic FDA data

510(k) DEN190032

Device
HemosIL Liquid Anti-Xa
Applicant
Instrumentation Laboratory CO
510(k) number
DEN190032
Product code
QLU
Decision
Unknown (DENG)
Decision date
2020-09-17
Date received
2019-06-25
Regulation
864.7295
Classification name
Anti-Factor Xa Activity Test System, Apixaban
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Direct
Third party reviewed
N

Applicant Contact#

Contact
Carol Marble
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QLU#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)Siemens Healthcare Diagnostics Products GmbH2024-10-10
K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO2023-06-23