Cleared Traditional

SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES

K060656 · Sysmex America, Inc. · Hematology
May 2006
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K060656 is an FDA 510(k) clearance for the SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES, 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 May 10, 2006, 58 days after receiving the submission on March 13, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K060656 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2006
Decision Date May 10, 2006
Days to Decision 58 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