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Simplify D-Dimer, Model DCGK1

by Agen Biomedical, Ltd.

510(k) K993276

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 NumberK993276 Date14 Dec 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0594-2007 FDA Unclassified (pre-2012) initiated 15 Feb 2007

    Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.

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  • Withdrawn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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