Home / 510(k) Clearances / K030964

510(k) K030964

CALIBRATION PLASMA LMW HEPARIN by Instrumentation Laboratory CO — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2003
Date Received
March 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
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 JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (November 7, 2003)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)
  • K022682 — RANDOX C-REACTIVE PROTEIN CALIBRATOR (November 5, 2002)