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Neoplastine(R) Ci Kit

by American Bioproducts Co.

510(k) K922565

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK922565 Date7 Dec 1992ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2994-2018 FDA Class II initiated 24 Jul 2018

    QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

    • Terminated Z-1068-2018 FDA Class II initiated 25 Oct 2017

    Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

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  • Withdrawn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
GJS
Device Class
Class II
Regulation
21 CFR Part 864.7750
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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