SYSMEX POCH-100I— 510(k) K032677

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K032677 for SYSMEX POCH-100I, Substantially Equivalent on 2004-02-11. Applicant: Sysmex America, Inc..

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code GKL
Advisory panel: Hematology
Date received: 2003-08-29
Decision date: 2004-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

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