|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
synchron systems lipid calibrator
|
BECKMAN COULTER, INC.
|
K983640 |
12/21/1998
|
synchron cx systems microalbumin calibrator
|
BECKMAN COULTER, INC.
|
K994325 |
01/12/2000
|
synchron cx systems prealbumin calibrator
|
BECKMAN COULTER, INC.
|
K994169 |
02/03/2000
|
synchron lx systems prealbumin calibrator
|
BECKMAN COULTER, INC.
|
K994168 |
02/03/2000
|
synchron lx systems microalbumin calibrator
|
BECKMAN COULTER, INC.
|
K000331 |
02/10/2000
|
access ostase immunoenzymetric assay
|
BECKMAN COULTER, INC.
|
K994278 |
03/28/2000
|
immage immunochemistry system lipoprotein(a) lpax reagent, array system lipoprotein(a) lpa reagent, lipoprotein(a) calib
|
BECKMAN COULTER, INC.
|
K000121 |
05/17/2000
|
beckman coulter dnase b calibrator
|
BECKMAN COULTER, INC.
|
K010696 |
05/10/2001
|
accutni and accutni calibrators on the access immunoassay system # 33340, 33345
|
BECKMAN COULTER, INC.
|
K010429 |
06/05/2001
|
synchron systems direct ldl chloesterol reagent and calibrator
|
BECKMAN COULTER, INC.
|
K014103 |
01/28/2002
|
|