Medical Device Manufacturer · US , Burlington , NC

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

7 submissions · 7 cleared · Since 1994

7

Total

7

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Dec 10, 1996

Toxicology · 85d

Cleared Oct 31, 1996

EZ-SCREEN PROFILE

Toxicology · 73d

Cleared Oct 30, 1996

Toxicology · 57d

Cleared Oct 30, 1996

VERDICT BARBITURATES

Toxicology · 56d

Cleared Nov 17, 1994

VERDICT OPIATES

Toxicology · 108d

Cleared Sep 09, 1994

Toxicology · 39d