Cala Diagnostics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Cala Diagnostics - FDA 510(k) Cleared Devices
12
Total
12
Cleared
0
Denied
Cala Diagnostics has 12 FDA 510(k) cleared chemistry devices. Based in Los Osos, US.
Historical record: 12 cleared submissions from 1985 to 1994.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Cala Diagnostics
12 devices
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
CARDIOCHEX
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
Jan 30, 1992
FIBRINOGEN FDP CONTROL
Hematology
52d
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
May 06, 1987
CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3
Toxicology
174d
Cleared
Jun 25, 1985
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
Chemistry
112d