|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
synchron systems enzyme validator set levels 1 and 2
|
BECKMAN COULTER, INC.
|
K984014 |
12/23/1998
|
beckman coulter immage immunochemistry system low concentration immunoglobulin a (igalc) reagent, beckman coulter cerebr
|
BECKMAN COULTER, INC.
|
K993549 |
02/01/2000
|
beckman coulter immage immunochemistry system low concentration immunoglobulin m (igmlc) reagent, beckman coulter cereb
|
BECKMAN COULTER, INC.
|
K993547 |
02/01/2000
|
modification to synchron systems enzyme validator set levels 1 and 2
|
BECKMAN COULTER, INC.
|
K032287 |
08/18/2003
|
synchron cx delta clinical systems, creatinine test systems
|
BECKMAN COULTER, INC.
|
K071280 |
06/01/2007
|
synchron lx20 clinical systems, creatinine test systems
|
BECKMAN COULTER, INC.
|
K071277 |
06/01/2007
|
immage immunochemistry systems high sensitivity cardiac c-reactive protein (ccrp) reagent
|
BECKMAN COULTER, INC.
|
K071002 |
06/21/2007
|
synchron multi calibrator
|
BECKMAN COULTER, INC.
|
K110251 |
05/25/2011
|
access total bhcg (5th is)
|
BECKMAN COULTER, INC.
|
K130020 |
10/01/2013
|
beckman coulter immage immunochemistry system low concentration immunoglobulin, beckman coulter
|
BECKMAN COULTER, INC
|
K130122 |
01/07/2014
|
|