EUROTROL HEMATOCRIT CONTROL— 510(k) K121467

Substantially Equivalent

Eurotrol B.V.

FDA 510(k) clearance K121467 for EUROTROL HEMATOCRIT CONTROL, Substantially Equivalent on 2013-05-10. Applicant: Eurotrol B.V.. Device class: 2.

Clearance details

Applicant: Eurotrol B.V.
Product code: Code GLK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2012-05-17
Decision date: 2013-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ede, NL

Download summary PDF View on FDA.gov ↗

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More clearances from Eurotrol B.V.

K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High2019-11-15
K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High2019-02-01
K152553 — CueSee Hypoxic2016-04-22
K131595 — EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM2013-07-26
K121468 — EUROTROL GAS-ISE METABOLITES2012-06-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.