Cleared Traditional

EUROTROL HEMATOCRIT CONTROL

K121467 · Eurotrol B.V. · Hematology
May 2013
Decision
358d
Days
Class 2
Risk

About This 510(k) Submission

K121467 is an FDA 510(k) clearance for the EUROTROL HEMATOCRIT CONTROL, a Control, Hematocrit (Class II — Special Controls, product code GLK), submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on May 10, 2013, 358 days after receiving the submission on May 17, 2012. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K121467 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2012
Decision Date May 10, 2013
Days to Decision 358 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GLK — Control, Hematocrit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625

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