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Flowcare System

by Pointcare Technologies, Inc.

510(k) K041882

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041882 Date23 Nov 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
GKZ
Device Class
Class II
Regulation
21 CFR Part 864.5220
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Flowcare System is a differential cell counter used for hematological analysis. It consists of an analysis instrument, a touch screen computer, and a standard inkjet printer.

This device is used in conjunction with the Flowcare CD4 Reagent Kit. It has received FDA 510(k) clearance.

Other devices from Pointcare Technologies, Inc.

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the primary purpose of the Flowcare System?

    The Flowcare System is designed for hematological analysis and functions as a differential cell counter to assist clinicians in evaluating blood samples.

  • What components are included with the Flowcare System?

    The system is supplied as a complete unit consisting of three main components: an analysis instrument, a touch screen computer for operation, and a standard inkjet printer for reporting results.

  • Does the Flowcare System require specific reagents to function?

    Yes, the Flowcare System is intended to be used in conjunction with the Flowcare CD4 Reagent Kit to perform its hematological analysis functions.

  • What is the regulatory status of the Flowcare System?

    The Flowcare System has received FDA 510(k) clearance, which indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices in the hematology category.