Home / 510(k) Clearances / K862253

510(k) K862253

IL 482 CO-OXIMETER by Instrumentation Laboratory CO — Product Code JKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1986
Date Received
June 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
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 JKS

  • K951485 — AVOXIMETER 4000 (November 6, 1995)
  • K863825 — CO-OXIMETER SOLUTIONS (November 24, 1986)
  • K853990 — OSM3 HEMOXIMETER (December 30, 1985)
  • K833693 — TEE ADAPTER 9890-FLUSH WINDING 282 (December 30, 1983)
  • K833211 — BILE SALTS MIXTURE (October 27, 1983)
  • K832066 — CONTROL 282 (September 29, 1983)
  • K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (July 27, 1978)