Home / 510(k) Clearances / K931116

510(k) K931116

IL TEST(TM) TRIGLYCERIDE by Instrumentation Laboratory CO — Product Code JGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
March 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Instrumentation Laboratory CO

  • K233790 — ACL TOP 970 CL (December 29, 2023)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein (September 29, 2023)
  • K223608 — GEM Premier 7000 with IQM3 (August 10, 2023)
  • K223187 — HemosIL Liquid Anti-Xa (June 23, 2023)
  • K231031 — ACL TOP Family 70 Series (June 21, 2023)
  • K223090 — GEM Premier ChemSTAT (January 27, 2023)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K213464 — HemosIL Liquid Anti-Xa (October 4, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)

Other clearances for product code JGY

  • K120664 — PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM (April 24, 2012)
  • K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM (January 24, 2003)
  • K000586 — BIOSCANNER TRIGLYCERIDES TEST STRIPS (July 3, 2000)
  • K991894 — BIOSCANNER TRIGLYCERIDES TEST STRIPS (May 24, 2000)
  • K971005 — TRIGLYCERIDES (April 21, 1997)
  • K954187 — TRIGLYCERIDES REAGENT (October 23, 1995)
  • K941063 — DNA TRIGLYCERIDE PROCEDURE (July 20, 1994)
  • K914033 — CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST (September 27, 1991)
  • K905226 — TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (December 11, 1990)
  • K902202 — DMA TRIGLYCERIDE (GPO) PROCEDURE (July 31, 1990)