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510(k) K201570

PF4 Enhanced assay by Immucor Gti Diagnostics, Inc. — Product Code LCO

K201570 is an FDA 510(k) premarket notification submitted by Immucor Gti Diagnostics, Inc. for the device "PF4 Enhanced assay". The FDA issued a decision of Substantially Equivalent on September 11, 2020. The device falls under product code LCO (Platelet Factor 4 Radioimmunoassay), a Class II device regulated under 21 CFR 864.7695. Immucor Gti Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2020
Date Received
June 11, 2020
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 Immucor Gti Diagnostics, Inc.

  • K201311 — PF4 IgG assay (June 18, 2020)

Other clearances for product code LCO

  • K243374 — HemosIL CL HIT-IgG(PF4-H) (January 28, 2025)
  • 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)
  • K983379 — GTI-PF4 ELISA (March 9, 1999)

FDA data resources