Cleared Traditional

SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER

K081890 · Sysmex America, Inc. · Hematology
Oct 2008
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K081890 is an FDA 510(k) clearance for the SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Sysmex America, Inc. (Mundelein, US). The FDA issued a Cleared decision on October 10, 2008, 100 days after receiving the submission on July 2, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K081890 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2008
Decision Date October 10, 2008
Days to Decision 100 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