Medical Device Manufacturer · US , East Stroudsburg , PA

Lehnus & Associates Consulting - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2005

Recent clearances: PREGNANCY ONE STEP RAPID TEST, IBL CORTISOL LIA TEST KIT

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lehnus & Associates Consulting Chemistry ✕

2 devices

1-2 of 2

Cleared Jul 28, 2011

PREGNANCY ONE STEP RAPID TEST

Chemistry · 234d

Cleared Oct 03, 2005

IBL CORTISOL LIA TEST KIT

Chemistry · 38d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 15, 2026