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DANAM ELEC. SA-1000

by Danam Electronics 510(k)

Active United States

510(k) K840649

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840649 Date19 Jul 1984ClearedStatusActive

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  • Withdrawn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
GKL
Device Class
Class II
Regulation
21 CFR Part 864.5200
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 DANAM ELEC. SA-1000 is an automated cell counter used in hematology. It is classified as a Class II medical device.

The device is supplied sterile and intended for single use. It is not MRI safe. The device is regulated under FDA 510(k) clearance.

Other devices from Danam Electronics

Questions

AI-generated answers, 26 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 DANAM ELEC. SA-1000 used for?

    The DANAM ELEC. SA-1000 is an automated cell counter designed for use in hematology to count cells.

  • Is the DANAM ELEC. SA-1000 sterile and intended for single use?

    Yes, the device is supplied sterile and is intended for single use.

  • Is the DANAM ELEC. SA-1000 MRI safe?

    No, the DANAM ELEC. SA-1000 is not MRI safe.

  • What is the regulatory status of the DANAM ELEC. SA-1000?

    The DANAM ELEC. SA-1000 is regulated under FDA 510(k) clearance.