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510(k) K040293

HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY by Akers Laboratories, Inc. — Product Code LCO

K040293 is an FDA 510(k) premarket notification submitted by Akers Laboratories, Inc. for the device "HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY". The FDA issued a decision of Substantially Equivalent on May 28, 2004. The device falls under product code LCO (Platelet Factor 4 Radioimmunoassay), a Class II device regulated under 21 CFR 864.7695. Akers Laboratories, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2004
Date Received
February 6, 2004
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 Akers Laboratories, Inc.

  • K031579 — INSTAREAD LITHIUM SYSTEM (December 19, 2003)
  • K030815 — AKERS LABORATORIES INC. BLOOD CELL SEPARATOR (September 17, 2003)

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)
  • K003767 — ASSERACHROM HPIA TEST KIT (February 12, 2001)
  • K983379 — GTI-PF4 ELISA (March 9, 1999)

FDA data resources