One Step Hcg Pregnancy Test - 2000 Miu/Ml, Model 100 Series.

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K052694 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• One Step Drug Test - Amp/Met/Mor/Thc/Coc

  Class II

  FDA 510(k) K060810 Active Cleared 7 Aug 2006

• Ind One Step Fecal Occult Blood Test Model 440-10

  Class II

  FDA 510(k) K100031 Active Cleared 19 Jul 2010

• Ind Urinary Tract Infection (Uti) Test Strips Open recall

  Class I

  FDA 510(k) K103037 Active Cleared 17 Apr 2012

• Ind Drug Home Multi-Panel Test (2-5) Ind Morphine Home Test

  Class II

  FDA 510(k) K121231 Active Cleared 30 Jul 2012

• One Step Fsh Menopausal Test Open recall

  Class I

  FDA 510(k) K052662 Active Cleared 30 Nov 2005

• Urine Chemistry Analyzer UR-50

  Class II

  FDA 510(k) K063390 Active Cleared 1 Mar 2007

See all devices from Ind Diagnostic, Inc. →