Cleared Traditional

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

K192842 · Eurotrol B.V. · Hematology
Nov 2019
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K192842 is an FDA 510(k) clearance for the HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High, a Control, Hemoglobin (Class II — Special Controls, product code GGM), submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on November 15, 2019, 43 days after receiving the submission on October 3, 2019. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K192842 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2019
Decision Date November 15, 2019
Days to Decision 43 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGM — Control, Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625