Medical Device Manufacturer · US , Lake Forest , CA

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

6 submissions · 6 cleared · Since 1990

6

Total

6

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Mar 19, 1996

SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)

Toxicology · 810d

Cleared Jul 14, 1995

SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE

Toxicology · 942d

Cleared Jul 14, 1995

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN...

Toxicology · 603d

Cleared Jul 14, 1995

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN...

Toxicology · 604d