Cleared Traditional

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

K182744 · Eurotrol B.V. · Hematology
Feb 2019
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K182744 is an FDA 510(k) clearance for the HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - 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 February 1, 2019, 126 days after receiving the submission on September 28, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K182744 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2018
Decision Date February 01, 2019
Days to Decision 126 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