|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
modification to roche diagnostics precinorm proteins in urine/csf (puc) and precipath proteins in urine/csf (puc)
|
ROCHE DIAGNOSTICS CORP.
|
K041812 |
07/27/2004
|
modification to:roche diagnostics precinorm universal and precipath universal control sera
|
ROCHE DIAGNOSTICS CORP.
|
K041227 |
05/27/2004
|
precinorm proteins in urine/csf precipath proteins in urine/csr controls
|
ROCHE DIAGNOSTICS CORP.
|
K040280 |
03/11/2004
|
ammonia/ethanol/co2 calibrator, control normal, control abnormal
|
ROCHE DIAGNOSTICS CORP.
|
K031880 |
07/16/2003
|
elecsys precicontrol multianalyte
|
ROCHE DIAGNOSTICS CORP.
|
K033937 |
01/07/2004
|
elecsys shbg immunoassay
|
ROCHE DIAGNOSTICS CORP.
|
K031717 |
08/05/2003
|
roche diagnostics elecsys precicontrol cardiac
|
ROCHE DIAGNOSTICS CORP.
|
K032089 |
07/30/2003
|
elecsys cortisol test system
|
ROCHE DIAGNOSTICS CORP.
|
K000270 |
03/07/2000
|
precinorm universal and precipath universal control sera
|
ROCHE DIAGNOSTICS CORP.
|
K992900 |
11/24/1999
|
precinorm universal plus and precipath universal plus control sera
|
ROCHE DIAGNOSTICS CORP.
|
K993360 |
11/24/1999
|