Cleared Traditional

ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)

K141161 · HORIBA ABX SAS · Hematology
Dec 2014
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K141161 is an FDA 510(k) clearance for the ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL), a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on December 20, 2014, 229 days after receiving the submission on May 5, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K141161 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2014
Decision Date December 20, 2014
Days to Decision 229 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220