HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High— 510(k) K192842

Name: FDA 510(k) clearance K192842
Creator: U.S. Food and Drug Administration
Published: 2019-11-15

Substantially Equivalent

Eurotrol B.V.

FDA 510(k) clearance K192842 for HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High, Substantially Equivalent on 2019-11-15. 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: 2019-10-03
Decision date: 2019-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ede, NL

Download summary PDF View on FDA.gov ↗

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