|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
c.f.a.s. proteins, c.f.a.s. pac, precicontrol clinchem multi 1 & 2, precinorm protein & precipath protein
|
Roche Diagnostics
|
K133330 |
11/26/2013
|
elecsys anti-tpo calset
|
Roche Diagnostics
|
K103171 |
02/11/2011
|
precinorm proteins in urine/csf (puc) and precipath puc
|
Roche Diagnostics
|
K050026 |
01/31/2005
|
roche diagnostics calibrator for automated systems, roche diagnostics calibrator calibrator for automated system
|
Roche Diagnostics
|
K101456 |
09/08/2010
|
total protein urine/csf gen.3
|
Roche Diagnostics
|
K071239 |
09/14/2007
|
ammonia/ethanol/co2 calibrator, control normal, control abnormal
|
ROCHE DIAGNOSTICS CORP.
|
K031880 |
07/16/2003
|
calibrator for automated systems
|
ROCHE DIAGNOSTICS CORP.
|
K011226 |
06/25/2001
|
calibrator for automated systems (c.f.a.s.)
|
ROCHE DIAGNOSTICS CORP.
|
K990460 |
03/22/1999
|
calibrator for automated systems (c.f.a.s.) proteins with model 11355279160
|
ROCHE DIAGNOSTICS CORP.
|
K080607 |
05/12/2008
|
calibrator for automated systems (c.f.a.s.), model 10759350 360
|
ROCHE DIAGNOSTICS CORP.
|
K062319 |
09/13/2006
|