Hcg Pregnancy One Step Test Strip for Otc Use

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K941765 ↗

FDA Product Code

LCX

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• One Step Lh Test

  Class I

  FDA 510(k) K935134 Active Cleared 11 Jan 1994

• Hcg Pregnancy One Step Test Strip

  Class II

  FDA 510(k) K923123 Active Cleared 9 Sep 1992

• One Step Urine Drug of Abuse Cocaine Test

  Class II

  FDA 510(k) K951892 Active Cleared 17 Aug 1995

• Health Check Uri-Test Protein in Urine

  Class I

  FDA 510(k) K972960 Active Cleared 7 Oct 1998

• One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine)

  Class II

  FDA 510(k) K952096 Active Cleared 17 Aug 1995

• One Step Urine Drug of Abuse: Benzodiazepine Test

  Class II

  FDA 510(k) K980776 Active Cleared 29 Apr 1998

See all devices from Tcpi, Inc. →