|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
access hypersensitive htsh assay
|
BECKMAN COULTER, INC.
|
K023093 |
11/25/2002
|
access ostase immunoenzymetric assay
|
BECKMAN COULTER, INC.
|
K994278 |
03/28/2000
|
access total t4 assay
|
BECKMAN COULTER, INC.
|
K023369 |
12/09/2002
|
access tsh (3rd is) assay and access tsh (3rd is) calibrators on the access immunoassay systems
|
BECKMAN COULTER, INC.
|
K153651 |
08/18/2016
|
accutni and accutni calibrators on the access immunoassay system # 33340, 33345
|
BECKMAN COULTER, INC.
|
K010429 |
06/05/2001
|
beckman coulter dnase b calibrator
|
BECKMAN COULTER, INC.
|
K010696 |
05/10/2001
|
ck-mb and ck-mb calibrators on the access immunoassay systems, models 386371 and 386372
|
BECKMAN COULTER, INC.
|
K030012 |
01/17/2003
|
cortisol and cortisol calibrators on the access immunoassay systems
|
BECKMAN COULTER, INC.
|
K050202 |
02/09/2005
|
immage immunochemistry system lipoprotein(a) lpax reagent, array system lipoprotein(a) lpa reagent, lipoprotein(a) calib
|
BECKMAN COULTER, INC.
|
K000121 |
05/17/2000
|
myoglobin and myoglobin calibrators on the access immunoassay systems, model 973243, 973244
|
BECKMAN COULTER, INC.
|
K021229 |
06/28/2002
|
|