Cleared Traditional

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

K170353 · HORIBA ABX SAS · Hematology
Nov 2017
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K170353 is an FDA 510(k) clearance for the ABX MICROS ES 60 OT and ABX MICROS ES 60 CT, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on November 1, 2017, 271 days after receiving the submission on February 3, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K170353 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2017
Decision Date November 01, 2017
Days to Decision 271 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