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510(k) K182744

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High by Eurotrol B.V. — Product Code GGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2019
Date Received
September 28, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hemoglobin
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Eurotrol B.V.

  • K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (November 15, 2019)
  • K152553 — CueSee Hypoxic (April 22, 2016)
  • K131595 — EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM (July 26, 2013)
  • K121467 — EUROTROL HEMATOCRIT CONTROL (May 10, 2013)
  • K121468 — EUROTROL GAS-ISE METABOLITES (June 22, 2012)
  • K060215 — ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 (March 24, 2006)

Other clearances for product code GGM

  • K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (November 15, 2019)
  • K070546 — LYPHOCHEK DIABETES CONTROL (April 2, 2007)
  • K070334 — R&D SICKLE QC CONTROL (March 29, 2007)
  • K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (November 9, 2005)
  • K032791 — GLYCOHEMOSURE HBA1C CONTROL (October 30, 2003)
  • K003030 — LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET (November 29, 2000)
  • K993321 — R&D HGB/GLC WHOLE BLOOD CONTROL (November 12, 1999)
  • K964052 — HEMOCUE HEMOTROL (November 6, 1996)
  • K963908 — HEMOCUE HEMOLIN (October 16, 1996)
  • K921681 — CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL (November 17, 1992)