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Crp-Latex (Ii)X2 Seiken Assay Kit

by Denka Seiken Co., Ltd.

510(k) K030545

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030545 Date2 Jun 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2631-2017 FDA Class III initiated 21 Jul 2009

    Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.

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  • Withdrawn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
DCK
Device Class
Class II
Regulation
21 CFR Part 866.5270
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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