Cala Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K944246CARDIOCHEX CKMB MASS MEASUREMENT CONTROLOctober 31, 1994
K944247CARDIOCHEX CKMB IMMUNOINHIBITION CONTROLOctober 31, 1994
K944243CARDIOCHEXOctober 27, 1994
K930874LD-1 CONTROL-LEVEL 1 & 2April 22, 1993
K930875CKMB CONTROL - LEVEL 1,2,3April 13, 1993
K930873CKMB ISOENZYME CONTROL-LEVEL 1,2.3April 13, 1993
K926015CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3December 28, 1992
K915503FIBRINOGEN FDP CONTROLJanuary 30, 1992
K912827SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3August 12, 1991
K912826WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2July 26, 1991
K864456CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3May 6, 1987
K850907CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/June 25, 1985