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510(k) K130236

RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 by Radiometer Medical Aps — Product Code JJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2013
Date Received
January 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controls For Blood-Gases, (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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Other clearances for product code JJS

  • K152553 — CueSee Hypoxic (April 22, 2016)
  • K150226 — Hematocrit and Metabolite QUALICHECK (May 13, 2015)
  • K130415 — HIGH METABOLITE QUALICHECK (March 26, 2013)
  • K033063 — MISSION CONTROLS (December 12, 2003)
  • K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 (August 15, 2002)
  • K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, A (August 15, 2002)
  • K003242 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (November 30, 2000)
  • K003239 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (November 30, 2000)
  • K002866 — LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (September 25, 2000)
  • K002865 — LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (September 25, 2000)