Skip to content

Platelet Aggregometers

by Chrono-Log Corp

510(k) K820422

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 5 Oct 2026.

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820422 Date16 Mar 1982ClearedStatusActive

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  • Withdrawn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
GHR
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, 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 Platelet Aggregometers are in-vitro diagnostic devices classified under the Reagent, Platelet Aggregation category, designed to measure platelet aggregation and ATP release from dense granules in platelet-rich plasma. These instruments assess platelet function, aiding in the diagnosis of inherited or acquired platelet disorders and monitoring treatment efficacy. They provide quantitative data on platelet reactivity, supporting clinical decision-making in hematology.

These devices are intended for use in clinical laboratory settings by trained laboratory technicians. They are supplied as reusable instruments and are not sterile by design, requiring appropriate cleaning and maintenance protocols between uses. The Platelet Aggregometers are regulated under FDA 510(k) clearance (K820422) and fall under Class II medical devices (Device Class: 2). Compliance with regulatory standards ensures their reliability for platelet function testing.

Similar devices

Other devices filed under FDA product code GHR (Reagent, Platelet Aggregation).

Other devices from Chrono-Log Corp

See all devices from Chrono-Log Corp →