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510(k) K192842

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

K192842 is an FDA 510(k) premarket notification submitted by Eurotrol B.V. for the device "HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High". The FDA issued a decision of Substantially Equivalent on November 15, 2019. The device falls under product code GGM (Control, Hemoglobin), a Class II device regulated under 21 CFR 864.8625. Eurotrol B.V. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2019
Date Received
October 3, 2019
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.

  • K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (February 1, 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

  • K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (February 1, 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)

FDA data resources