Home / 510(k) Clearances / K993553

510(k) K993553

GTI-FVIII INHIBITOR ASSAY by Genetic Testing Institute — Product Code GGP

K993553 is an FDA 510(k) premarket notification submitted by Genetic Testing Institute for the device "GTI-FVIII INHIBITOR ASSAY". The FDA issued a decision of Substantially Equivalent on February 1, 2000. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Genetic Testing Institute has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2000
Date Received
October 20, 1999
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

Other clearances by Genetic Testing Institute

  • K082205 — FACTOR VIII ANTIBODY SCREEN (November 20, 2008)
  • K071781 — PF4 IGG (December 19, 2007)
  • K053559 — PF4 ENHANCED SOLID PHASE ELISA (January 20, 2006)
  • K983379 — GTI-PF4 ELISA (March 9, 1999)
  • K841114 — ALLO-TYPE HUMAN IMMUNOGLOBULIN- (June 14, 1984)

Other clearances for product code GGP

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • 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)

FDA data resources