More Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELJanuary 30, 2008
K050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4March 18, 2005
K982845CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3August 21, 1998
K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVMarch 16, 1998
K972976CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELAugust 29, 1997
K970778LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4April 17, 1997
K946193FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3August 24, 1995
K943571MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTSJune 15, 1995
K944999SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3June 6, 1995
K941698SERUM VOLATILES CONTROL - LEVELS 1 AND 2July 28, 1994
K941876WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2July 28, 1994
K932657FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2November 2, 1993
K932660LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2October 28, 1993
K932658CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3July 28, 1993
K932659MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUMJuly 28, 1993
K932662CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVELJuly 26, 1993