|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
calibrator for automated systems (c.f.a.s.)
|
ROCHE DIAGNOSTICS CORP.
|
K990460 |
03/22/1999
|
elecsys cortisol calcheck
|
ROCHE DIAGNOSTICS CORP.
|
K000576 |
03/21/2000
|
roche diagnostics ck-mb
|
ROCHE DIAGNOSTICS CORP.
|
K003158 |
12/18/2000
|
calibrator for automated systems
|
ROCHE DIAGNOSTICS CORP.
|
K011226 |
06/25/2001
|
ammonia/ethanol/co2 calibrator, control normal, control abnormal
|
ROCHE DIAGNOSTICS CORP.
|
K031880 |
07/16/2003
|
modification to calibrator for automatic systems (cfas)
|
ROCHE DIAGNOSTICS CORP.
|
K033501 |
11/20/2003
|
elecsys c-peptide calset
|
ROCHE DIAGNOSTICS CORP.
|
K033873 |
02/13/2004
|
calibrator for automated systems prealbumin-aslo-ceruloplasmin (c.f.a.s. pac)
|
ROCHE DIAGNOSTICS CORP.
|
K040245 |
03/24/2004
|
calibrator for automated systems proteins in urine/csf
|
ROCHE DIAGNOSTICS CORP.
|
K040264 |
04/02/2004
|
precinorm proteins in urine/csf (puc) and precipath puc
|
Roche Diagnostics
|
K050026 |
01/31/2005
|