Cleared Traditional

ABX PENTRA DX 120: OPTION SPS EVOLUTION

K050719 · Horiba Abx · Hematology
Apr 2005
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K050719 is an FDA 510(k) clearance for the ABX PENTRA DX 120: OPTION SPS EVOLUTION, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on April 26, 2005, 36 days after receiving the submission on March 21, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K050719 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2005
Decision Date April 26, 2005
Days to Decision 36 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