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Bed Red D-Dimer Whole Blood Agglutination Assay

by Agen Biomedical, Ltd.

510(k) K905643

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905643 Date12 Apr 1991ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0314-2017 FDA Class II initiated 1 Jun 2016

    A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negative results are possible which may incorrectly influence the clinical diagnostic decision.

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  • Withdrawn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
FDA applicant
Agen Biomedical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 864.7320
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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