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510(k) K071255

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A by Hyphen Biomed — Product Code LCO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2007
Date Received
May 4, 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

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  • K071781 — PF4 IGG (December 19, 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)