Cleared Traditional

SYSMEX POCH-100I

K032677 · Sysmex America, Inc. · Hematology
Feb 2004
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K032677 is an FDA 510(k) clearance for the SYSMEX POCH-100I, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Sysmex America, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 11, 2004, 166 days after receiving the submission on August 29, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K032677 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2003
Decision Date February 11, 2004
Days to Decision 166 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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