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Aggro/Link vW Cofactor Software

by Chrono-Log Corp

510(k) K940792

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK940792 Date13 Oct 1994ClearedStatusActive

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  • Withdrawn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
JOZ
FDA applicant
Chrono-Log Corp.
Device class
Class II
Regulation
21 CFR Part 864.5700
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 Aggro/Link vW Cofactor Software is an automated platelet aggregation system designed for hematological analysis. It facilitates the assessment of von Willebrand factor (vWf) activity and platelet function by simulating aggregometry tests, aiding in the diagnosis and monitoring of bleeding disorders such as von Willebrand disease.

This software is intended for use in clinical laboratories and research settings, operating as part of an automated platelet aggregation system. Supplied as a digital solution, it requires compatibility with the manufacturer’s hardware and is classified under FDA regulation 864.5700. The device holds a 510(k) clearance (K940792) and is categorized as a Class II medical device, adhering to hematology-specific standards for platelet function testing.

Devices cleared under K940792

2 devices · 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 K940792
UDI-DISize and differences
CHRONO-LOG vW CoFactor Opti8 Software
CHRONO-LOG CORP
vW CoFactor Opti8 Software00811476011670 —On the market
CHRONO-LOG vW CoFactor Software
CHRONO-LOG CORP
vW CoFactor Software00811476011045 —On the market

Similar devices

Other devices filed under FDA product code JOZ (System, Automated Platelet Aggregation).

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