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Platelet Aggregation Reagents

by Chrono-Log Corp

510(k) K922800

Active European Union and United States

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K922800↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK922800 Date26 Aug 1992ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K922800 decided 26 Aug 1992 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 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 Platelet Aggregation Reagents are diagnostic reagents designed to evaluate platelet function by inducing aggregation in whole blood or platelet-rich plasma. These reagents facilitate the assessment of platelet reactivity, aiding in the diagnosis and monitoring of bleeding disorders, thrombotic conditions, and the effectiveness of antiplatelet therapies.

These reagents are supplied in concentrated forms, requiring minimal volumes per test, and are intended for use in hematology laboratories. They are classified as Class II devices under FDA regulations and comply with the In Vitro Diagnostic Regulation (IVDR). The reagents are not sterile and are intended for single-use, with specific product codes (e.g., GHR) and registration numbers (e.g., 1618982) for traceability.

Devices cleared under K922800

6 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 K922800
UDI-DISize and differences
CHRONO-PAR 384
CHRONO-LOG CORP
38400811476010048 —On the market
CHRONO-PAR 385
CHRONO-LOG CORP
38500811476010055 —On the market
CHRONO-PAR 386
CHRONO-LOG CORP
38600811476010147 —On the market
CHRONO-PAR 387
CHRONO-LOG CORP
38700811476010062 —On the market
CHRONO-PAR 393
CHRONO-LOG CORP
39300811476010307 —On the market
CHRONO-PAR 396
CHRONO-LOG CORP
39600811476010086 —On the market

Similar devices

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

Other devices from Chrono-Log Corp

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