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510(k) K053559

PF4 ENHANCED SOLID PHASE ELISA by Genetic Testing Institute — Product Code LCO

K053559 is an FDA 510(k) premarket notification submitted by Genetic Testing Institute for the device "PF4 ENHANCED SOLID PHASE ELISA". The FDA issued a decision of Substantially Equivalent on January 20, 2006. The device falls under product code LCO (Platelet Factor 4 Radioimmunoassay), a Class II device regulated under 21 CFR 864.7695. Genetic Testing Institute has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2006
Date Received
December 21, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Platelet Factor 4 Radioimmunoassay
Device Class
Class II
Regulation Number
864.7695
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)
  • K993553 — GTI-FVIII INHIBITOR ASSAY (February 1, 2000)
  • K983379 — GTI-PF4 ELISA (March 9, 1999)
  • K841114 — ALLO-TYPE HUMAN IMMUNOGLOBULIN- (June 14, 1984)

Other clearances for product code LCO

  • K243374 — HemosIL CL HIT-IgG(PF4-H) (January 28, 2025)
  • K201570 — PF4 Enhanced assay (September 11, 2020)
  • K201311 — PF4 IgG assay (June 18, 2020)
  • K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls (September 8, 2017)
  • K153137 — HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls (July 8, 2016)
  • K071781 — PF4 IGG (December 19, 2007)
  • K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (September 7, 2007)
  • K040293 — HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY (May 28, 2004)
  • K003767 — ASSERACHROM HPIA TEST KIT (February 12, 2001)
  • K983379 — GTI-PF4 ELISA (March 9, 1999)

FDA data resources