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Sysmex POCH-100I

by Sysmex America, Inc.

510(k) K032677

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032677 Date11 Feb 2004ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0100-2014 FDA Class II initiated 15 May 2013 on shared 510(k) K032677

    The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

2 dated events

  1. Cleared FDA 510(k) K032677
  2. Recall initiated FDA recalls Z-0100-2014

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GKL
Device class
Class II
Regulation
21 CFR Part 864.5200
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sysmex Poch-100i is an automated cell counter designed for hematology applications. It performs automated differential and complete blood counts, including measurements of red blood cells, white blood cells, platelets, and hemoglobin levels, providing rapid and precise hematological analysis.

This device is intended for use in clinical laboratories processing up to 30 samples per day. Supplied as a reusable instrument, it requires proper maintenance and calibration as outlined in its instructions for use. The Poch-100i is classified under FDA 510(k) clearance (K032677) and adheres to regulatory standards for automated hematology analyzers, ensuring compliance with medical device regulations.

Similar devices

Other devices filed under FDA product code GKL (Counter, Cell, Automated (Particle Counter)).

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