Cleared Traditional

PENTRA XLR

K151133 · HORIBA ABX SAS · Hematology
Dec 2015
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K151133 is an FDA 510(k) clearance for the PENTRA XLR, 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 December 9, 2015, 225 days after receiving the submission on April 28, 2015. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K151133 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2015
Decision Date December 09, 2015
Days to Decision 225 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