Medical Device Manufacturer · US , Lenexa , KS

Labone, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2004

Recent clearances: LABONE COCAINE METABOLITE MICRO-PLATE EIA, LABONE MICRO-PLATE COTININE EIA

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Labone, Inc. Toxicology ✕

2 devices

1-2 of 2

Cleared Mar 05, 2004

LABONE COCAINE METABOLITE MICRO-PLATE EIA

Toxicology · 36d

Cleared Feb 10, 2004

LABONE MICRO-PLATE COTININE EIA

Toxicology · 88d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Oct 11, 2026