Medical Device Manufacturer · US , Los Osos , CA

More Diagnostics - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1993

16

Total

16

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared Aug 21, 1998

CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1,...

Chemistry · 9d

Cleared Aug 29, 1997

CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL

Chemistry · 18d

Cleared Apr 17, 1997

LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

Chemistry · 44d

Cleared Jun 06, 1995

SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3

Chemistry · 236d

Cleared Jul 28, 1994

SERUM VOLATILES CONTROL - LEVELS 1 AND 2

Chemistry · 113d

Cleared Jul 28, 1994

WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2

Chemistry · 101d

Cleared Oct 28, 1993

LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2

Chemistry · 148d

Cleared Jul 28, 1993

CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3

Chemistry · 56d

Cleared Jul 28, 1993

MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM

Chemistry · 56d