|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
access hybritech p2psa qc on the access immunoassay systems
|
BECKMAN COULTER, INC.
|
K112603 |
11/04/2011
|
access sex hormone binding globulin reagent, access sex hormone binding globulin calibrators and access sex hormone bind
|
BECKMAN COULTER, INC.
|
K083867 |
08/27/2009
|
access stfr, access stfr calibrators, and access stfr qc with models, a32493, a32494, and a32495
|
BECKMAN COULTER, INC.
|
K080634 |
08/11/2008
|
inhibin a calibrators & controls on the access immunoassay systems
|
BECKMAN COULTER, INC.
|
K070144 |
02/01/2007
|
instrinsic factor ab, calibrators, and qc on the access immunoassay systems, models 387992, 387993, 387999
|
BECKMAN COULTER, INC.
|
K033603 |
12/19/2003
|
vigil dnase b control
|
BECKMAN COULTER, INC.
|
K010693 |
04/11/2001
|
accutni qc on the access immunoassay system #33349
|
BECKMAN COULTER, INC.
|
K010428 |
03/13/2001
|
synchron control
|
BECKMAN COULTER, INC.
|
K001458 |
06/02/2000
|
access hybritech psa qc, model 37209
|
BECKMAN COULTER, INC.
|
K994200 |
01/18/2000
|
access ostase qc
|
BECKMAN COULTER, INC.
|
K994277 |
01/14/2000
|
|