Cleared Traditional

SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER

K081610 · Sysmex America, Inc. · Hematology
Aug 2008
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K081610 is an FDA 510(k) clearance for the SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER, 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 August 29, 2008, 81 days after receiving the submission on June 9, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K081610 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2008
Decision Date August 29, 2008
Days to Decision 81 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