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510(k) K071781

PF4 IGG by Genetic Testing Institute — Product Code LCO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2007
Date Received
July 2, 2007
Clearance Type
Traditional
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

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  • 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

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  • 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)
  • K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (September 7, 2007)
  • K053559 — PF4 ENHANCED SOLID PHASE ELISA (January 20, 2006)
  • 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)