|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
roche elecsys folate iii, roche elecsys rbc folate hemolysing reagent, roche elecsys folate iii calset, roche elecsys
|
ROCHE DIAGNOSTICS CORP.
|
K082340 |
06/19/2009
|
tdm control set, model cat# 04521536
|
ROCHE DIAGNOSTICS CORP.
|
K070200 |
03/19/2007
|
cobas integra ceruloplasmin
|
ROCHE DIAGNOSTICS CORP.
|
K062379 |
01/31/2007
|
tdm control set
|
ROCHE DIAGNOSTICS CORP.
|
K060429 |
03/15/2006
|
elecsys precicontrol bone
|
ROCHE DIAGNOSTICS CORP.
|
K051543 |
10/17/2005
|
elecsys precicontrol universal
|
ROCHE DIAGNOSTICS CORP.
|
K051687 |
07/25/2005
|
elecsys ca 19-9 calcheck
|
ROCHE DIAGNOSTICS CORP.
|
K051185 |
07/06/2005
|
elecsys precicontrol anemia
|
ROCHE DIAGNOSTICS CORP.
|
K051517 |
07/05/2005
|
roche diagnostics elecsys precicontrol tumor
|
ROCHE DIAGNOSTICS CORP.
|
K050387 |
04/25/2005
|
modification to precinorm universal plus and precipath universal plus control sera
|
ROCHE DIAGNOSTICS CORP.
|
K042389 |
09/14/2004
|