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Microsample Coagulation Analyzer

by Bio/Data Corp.

510(k) K943153

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

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 NumberK943153 Date24 Mar 1995ClearedStatusActive

Official records

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  • Withdrawn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
GKP
Device class
Class II
Regulation
21 CFR Part 864.5400
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 Microsample Coagulation Analyzer MCA 310-C is an automated coagulation instrument designed for hematology applications. It performs coagulation testing by analyzing small blood samples to measure clotting times and platelet aggregation, supporting diagnostic assessments of bleeding disorders and coagulation disorders.

This device is intended for use in clinical laboratory settings and has received FDA 510(k) clearance under the product code GKP. It operates as a reusable instrument, adhering to regulatory standards outlined in 21 CFR 864.5400. The analyzer is classified as a Class II medical device and is supplied with appropriate reagents for coagulation testing.

Similar devices

Other devices filed under FDA product code GKP (Instrument, Coagulation, Automated).

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