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510(k) K983379

GTI-PF4 ELISA by Genetic Testing Institute — Product Code LCO

K983379 is an FDA 510(k) premarket notification submitted by Genetic Testing Institute for the device "GTI-PF4 ELISA". The FDA issued a decision of Substantially Equivalent on March 9, 1999. 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
March 9, 1999
Date Received
September 25, 1998
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

  • K082205 — FACTOR VIII ANTIBODY SCREEN (November 20, 2008)
  • K071781 — PF4 IGG (December 19, 2007)
  • K053559 — PF4 ENHANCED SOLID PHASE ELISA (January 20, 2006)
  • K993553 — GTI-FVIII INHIBITOR ASSAY (February 1, 2000)
  • 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)
  • 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)

FDA data resources