Medical Device Manufacturer · US , Los Osos , CA

Cala Diagnostics - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1985

12

Total

12

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared Oct 31, 1994

CARDIOCHEX CKMB MASS MEASUREMENT CONTROL

Chemistry · 61d

Cleared Oct 31, 1994

CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL

Chemistry · 61d

Cleared Oct 27, 1994

Chemistry · 57d

Cleared Apr 22, 1993

LD-1 CONTROL-LEVEL 1 & 2

Chemistry · 62d

Cleared Apr 13, 1993

CKMB ISOENZYME CONTROL-LEVEL 1,2.3

Chemistry · 53d

Cleared Apr 13, 1993

CKMB CONTROL - LEVEL 1,2,3

Chemistry · 53d

Cleared Dec 28, 1992

CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3

Chemistry · 28d

Cleared Aug 12, 1991

SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3

Chemistry · 47d

Cleared Jul 26, 1991

WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2

Chemistry · 30d

Cleared Jun 25, 1985

CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/

Chemistry · 112d