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Device Name
|
Applicant
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510(K) Number
|
Decision Date
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modification to roche diagnostics precinorm proteins in urine/csf (puc) and precipath proteins in urine/csf (puc)
|
ROCHE DIAGNOSTICS CORP.
|
K041812 |
07/27/2004
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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
|
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
|
roche diagnostics elecsys precicontrol cardiac
|
ROCHE DIAGNOSTICS CORP.
|
K032089 |
07/30/2003
|
roche diagnostics elecsys precicontrol tumor
|
ROCHE DIAGNOSTICS CORP.
|
K050387 |
04/25/2005
|
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
|
ROCHE DIAGNOSTICS CORP.
|
K060429 |
03/15/2006
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tdm control set, model cat# 04521536
|
ROCHE DIAGNOSTICS CORP.
|
K070200 |
03/19/2007
|