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