Home / 510(k) Clearances / K121467

510(k) K121467

EUROTROL HEMATOCRIT CONTROL by Eurotrol B.V. — Product Code GLK

K121467 is an FDA 510(k) premarket notification submitted by Eurotrol B.V. for the device "EUROTROL HEMATOCRIT CONTROL". The FDA issued a decision of Substantially Equivalent on May 10, 2013. The device falls under product code GLK (Control, Hematocrit), 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
May 10, 2013
Date Received
May 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hematocrit
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)
  • 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)
  • 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 GLK

  • K021924 — MEDICA EASYQC HEMATOCRIT CONTROL (June 24, 2002)
  • K020618 — AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL (May 14, 2002)
  • K964452 — HEMATACHEK (February 20, 1997)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (July 26, 1996)
  • K924926 — MSI-HCT (January 7, 1993)
  • K893562 — A.QC HCT LEVEL 1 AND 2 (July 14, 1989)

FDA data resources