Medical Device Manufacturer · US , Los Osos , CA

More Diagnostics - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1993

Recent clearances: MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL, RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4, CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - More Diagnostics Toxicology ✕

4 devices

1-4 of 4

Cleared Jan 30, 2008

MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL

Toxicology · 170d

Cleared Mar 18, 2005

RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4

Toxicology · 58d

Cleared Mar 16, 1998

IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT...

Toxicology · 47d

Cleared Jul 26, 1993

CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL

Toxicology · 54d