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Staclot(R) Protein S Test Kit

by American Bioproducts Co.

510(k) K913424

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK913424 Date8 Oct 1991ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3047-2026 FDA Class II initiated 29 Jul 2026

    A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified

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  • Withdrawn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
GGP
Device Class
Class II
Regulation
21 CFR Part 864.7290
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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