Skip to content

Citrex II

by Bio/Data Corp.

510(k) K853077

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 NumberK853077 Date12 Aug 1985ClearedStatusActive

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  • Withdrawn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
JPA
Device class
Class II
Regulation
21 CFR Part 864.5425
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Citrex II is a System, Multipurpose for In Vitro Coagulation Studies, designed for hematological analysis. It functions as a platelet aggregometer and coagulation analyzer, enabling the assessment of platelet function and blood clotting mechanisms through in vitro testing. The device supports multiple coagulation assays, providing quantitative measurements of platelet aggregation and other hemostatic parameters essential for diagnostic evaluation.

This system is intended for use in clinical hematology laboratories and research settings. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accurate results. The Citrex II adheres to FDA regulatory standards, having received FDA 510(k) clearance under the classification of Class II devices (K853077). It operates within the scope of regulation number 864.5425 and is intended for in vitro diagnostic use only, with no MRI safety considerations specified.

Devices cleared under K853077

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K853077
UDI-DISize and differences
Sodium Citrate 100994
Bio/Data Corporation
100994 / 100994G0561009940 —On the market

Similar devices

Other devices filed under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies).

Other devices from Bio/Data Corp.

See all devices from Bio/Data Corp. →