Skip to content

Citrex I

by Bio/Data Corp.

510(k) K853076

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 NumberK853076 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  • Withdrawn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, 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 Citrex I is a System, Multipurpose for In Vitro Coagulation Studies, designed for hematological analysis. It functions as a platelet aggregometer and related coagulation testing device, enabling quantitative assessment of platelet function and blood clotting dynamics in vitro. The system supports multiple coagulation assays, including aggregation studies, to aid in diagnostic evaluations of hematological disorders.

This device is intended for use in clinical or research laboratory settings, where trained personnel perform in vitro coagulation studies. Supplied as a reusable system, it requires proper calibration and maintenance to ensure accurate results. The Citrex I adheres to FDA regulatory standards under 510(k) clearance (K853076), with a classification as a Class II medical device (Regulation Number 864.5425). No sterility claims are specified, and its operation is not restricted by MRI safety considerations.

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. →