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510(k) K243374

HemosIL CL HIT-IgG(PF4-H) by Instrumentation Laboratory (IL) Co. — Product Code LCO

K243374 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory (IL) Co. for the device "HemosIL CL HIT-IgG(PF4-H)". The FDA issued a decision of Substantially Equivalent on January 28, 2025. The device falls under product code LCO (Platelet Factor 4 Radioimmunoassay), a Class II device regulated under 21 CFR 864.7695. Instrumentation Laboratory (IL) Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2025
Date Received
October 30, 2024
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 Instrumentation Laboratory (IL) Co.

  • K260551 — HemosIL Factor V Leiden (APC Resistance V) (March 20, 2026)
  • K253957 — HemosIL Silica Clotting Time (January 9, 2026)
  • K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (July 24, 2025)
  • K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP (August 16, 2024)

Other clearances for product code LCO

  • 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)
  • K983379 — GTI-PF4 ELISA (March 9, 1999)

FDA data resources