HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High— 510(k) K182744

Name: FDA 510(k) clearance K182744
Creator: U.S. Food and Drug Administration
Published: 2019-02-01

Substantially Equivalent

Eurotrol B.V.

FDA 510(k) clearance K182744 for HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High, Substantially Equivalent on 2019-02-01. Applicant: Eurotrol B.V.. Device class: 2.

Clearance details

Applicant: Eurotrol B.V.
Product code: Code GGM
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2018-09-28
Decision date: 2019-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ede, NL

Download summary PDF View on FDA.gov ↗

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