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Healgen Hcg One Step Pregnancy Test (Strip), Healgen Hcg One Step Pregnancy Test (Cassette)

by Healgen Scientific, , LLC

510(k) K123703

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

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 NumberK123703 Date10 Apr 2013ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-0264-2024 FDA Class II initiated 4 Oct 2023

    Products were stored outside of labeled temperature requirements.

  • 2 recalls, same reason

    • Ongoing Z-1527-2022 FDA Class II initiated 23 Jun 2022
    • Ongoing Z-1528-2022 FDA Class II initiated 23 Jun 2022

    Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

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  • Withdrawn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
LCX
FDA applicant
Healgen Scientific,, LLC
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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