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DATACELL 18MS

by Danam Electronics 510(k)

Active United States

510(k) K945678

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945678 Date12 Sep 1995ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 1 Oct 2026

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

The DATACELL 18MS is a specialized device used in TACE procedures, which are minimally invasive treatments for liver cancer. It is classified as a Class 2 device under product code GKZ and is manufactured by Danam Electronics.

The device was cleared through the FDA 510(k) pathway on September 12, 1995, with K number K945678. It is used for performing a five-part white cell differential and is supplied in various sizes as specified in the device data.

Other devices from Danam Electronics

Questions

AI-generated answers, 1 Oct 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 DATACELL 18MS used for?

    The DATACELL 18MS is a specialized device used in TACE procedures, which are minimally invasive treatments for liver cancer. It is designed for performing a five-part white cell differential analysis during these procedures.

  • How is the DATACELL 18MS supplied?

    The device is supplied in various sizes as specified in the device data. The specific size options and packaging configurations are detailed in the manufacturer's specifications for this model.

  • What is the regulatory status of the DATACELL 18MS?

    The DATACELL 18MS is classified as a Class 2 device under product code GKZ. It was cleared through the FDA 510(k) pathway on September 12, 1995, with K number K945678, and is manufactured by Danam Electronics.

  • Is the DATACELL 18MS a single-use device?

    The device data does not specify whether the DATACELL 18MS is designed for single-use or reuse. This information should be obtained directly from the manufacturer's instructions for use or product documentation.