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Pathfast D-Dimer

by Mitsubishi Kagaku Iatron

510(k) K072288

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072288 Date6 May 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0646-2017 FDA Class II initiated 16 Aug 2016

    Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.

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  • Withdrawn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
GHH
Device Class
Class II
Regulation
21 CFR Part 864.7320
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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