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FDA 510(k) Applications for Medical Device Product Code "QLU"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN190032
Instrumentation Laboratory Co.
HemosIL Liquid Anti-Xa
09/17/2020
K223187
Instrumentation Laboratory Co.
HemosIL Liquid Anti-Xa
06/23/2023
K240315
Siemens Healthcare Diagnostics Products GmbH
INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
10/10/2024
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