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.. Device class: 2.

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 2003-08-29
Decision date: 2004-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sysmex America, Inc.

Recalls naming K032677

K-number listed on FDA's recall record

Z-0100-2014 — pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).Class II·Terminated·Sysmex America Inc·20130515

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032677.

Data sourced from openFDA. This site is unofficial and independent of the FDA.