Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Applications Submitted by CORINA HARPER
FDA 510(k) Number
Submission Date
Device Name
Applicant
K060108
01/13/2006
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
ROCHE DIAGNOSTICS CORP.
K061048
04/17/2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
ROCHE DIAGNOSTICS CORP.
K071211
05/01/2007
COBAS C 111 ANALYZER
Roche Diagnostics
K071239
05/03/2007
TOTAL PROTEIN URINE/CSF GEN.3
Roche Diagnostics
K051185
05/09/2005
ELECSYS CA 19-9 CALCHECK
ROCHE DIAGNOSTICS CORP.
K051687
06/23/2005
ELECSYS PRECICONTROL UNIVERSAL
ROCHE DIAGNOSTICS CORP.
K062114
07/24/2006
CERULOPLASMIN, MODEL 2055953
ROCHE DIAGNOSTICS CORP.
K052002
07/25/2005
IRON STANDARD
ROCHE DIAGNOSTICS CORP.
K062319
08/09/2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
ROCHE DIAGNOSTICS CORP.
K052193
08/11/2005
ISE COMPENSATOR
Roche Diagnostics
K062379
08/15/2006
COBAS INTEGRA CERULOPLASMIN
ROCHE DIAGNOSTICS CORP.
K063543
11/24/2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
ROCHE DIAGNOSTICS CORP.
K063744
12/18/2006
COBAS INTEGRA C 111
ROCHDIAG
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact