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Mascot MD Hematology Analyzer Model MD 700

by Cdc Technologies, Inc.

510(k) K983562

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 · Special NumberK983562 Date3 Nov 1998ClearedStatusActive

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  • Withdrawn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, 21 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 Mascot MD Hematology Analyzer Model MD 700 is a counter, differential cell device used for in vitro analysis of human peripheral blood. It is classified as a hematology analyzer and is substantially equivalent to a predicate device under FDA 510(k) clearance K983562.

The device is intended for use in clinical laboratories and processes 20 µL of EDTA-treated whole blood using motorized syringes and valves to mix blood with reagents. It is supplied as a reusable analyzer and is regulated under FDA product code GKZ and regulation number 864.5220.

Other devices from Cdc Technologies, Inc.

Questions

AI-generated answers, 21 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 Mascot MD Hematology Analyzer Model MD 700 used for?

    It is used for in vitro analysis of human peripheral blood as a counter and differential cell device, specifically designed to count and differentiate blood cells in clinical laboratory settings using EDTA-treated whole blood samples.

  • How is the Mascot MD Hematology Analyzer Model MD 700 supplied and is it reusable?

    The device is supplied as a reusable analyzer, meaning it is designed for multiple uses after proper cleaning and maintenance, and is not intended as a single-use disposable unit.

  • What sample volume and type does the Mascot MD Hematology Analyzer Model MD 700 require?

    It requires 20 µL of EDTA-treated whole blood per test, which is mixed with reagents using internal motorized syringes and valves to enable accurate cell counting and differentiation.

  • What regulatory pathway and product code apply to the Mascot MD Hematology Analyzer Model MD 700?

    The device received FDA 510(k) clearance under K983562 and is regulated under FDA product code GKZ and regulation number 864.5220, confirming its classification as a Class II hematology analyzer.