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510(k) DEN190032

HemosIL Liquid Anti-Xa by Instrumentation Laboratory CO — Product Code QLU

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.

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  • K223608 — GEM Premier 7000 with IQM3 (August 10, 2023)
  • K223187 — HemosIL Liquid Anti-Xa (June 23, 2023)
  • K231031 — ACL TOP Family 70 Series (June 21, 2023)
  • K223090 — GEM Premier ChemSTAT (January 27, 2023)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K213464 — HemosIL Liquid Anti-Xa (October 4, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)

Other clearances for product code QLU

  • K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Api (October 10, 2024)
  • K223187 — HemosIL Liquid Anti-Xa (June 23, 2023)