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510(k) K230852

HemosIL Chromogenic Factor IX by Instrumentation Laboratory Company — Product Code GGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2023
Date Received
March 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

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  • K231031 — ACL TOP Family 70 Series (June 21, 2023)
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  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K213464 — HemosIL Liquid Anti-Xa (October 4, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)
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Other clearances for product code GGP

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K220728 — vWF Ag (June 2, 2023)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K200033 — HemosIL von Willebrand Factor Antigen (August 19, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)
  • K102164 — HEMOSIL PROTEIN S ACTIVITY ASSAY (March 17, 2011)