FDA 510(k) Applications Submitted by THERESA M AMBROSE

FDA 510(k) Number Submission Date Device Name Applicant
K070172 01/18/2007 AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE DIAGNOSTICS CORPORATION
K070174 01/18/2007 AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY ROCHE DIAGNOSTICS CORPORATION
K061683 06/15/2006 TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K062203 08/01/2006 TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K062239 08/02/2006 GLUCOSE HK NEW FORMULATION TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K063684 12/12/2006 COBAS LITHIUM ROCHE DIAGNOSTICS CORP.
K063823 12/26/2006 COAGUCHEK XS PT CONTROLS ROCHE DIAGNOSTICS CORP.
K031698 06/02/2003 ELECYS SHBG CALCHECK ROCHE DIAGNOSTICS CORP.
K050026 01/06/2005 PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC Roche Diagnostics
K050113 01/18/2005 TINA-QUANT IGG GEN.2 ROCHE DIAGNOSTICS CORP.
K040157 01/23/2004 ELECSYS C-PEPTIDE CALCHECK ROCHE DIAGNOSTICS CORP.
K040245 02/03/2004 CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) ROCHE DIAGNOSTICS CORP.
K040733 03/22/2004 ELECSYS TROPONIN T STAT TEST ROCHE DIAGNOSTICS CORP.
K061093 04/19/2006 CHOLINESTERASE GEN.2 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K031299 04/24/2003 ELECSYS LH CALSET II ROCHE DIAGNOSTICS CORP.
K041227 05/10/2004 MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA ROCHE DIAGNOSTICS CORP.
K051382 05/27/2005 ELECSYS PROBNP IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K031717 06/03/2003 ELECSYS SHBG IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K031990 06/27/2003 ELECSYS PRECICONTROL TROPONIN T ROCHE DIAGNOSTICS CORP.
K051752 06/29/2005 ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) Roche Diagnostics
K041812 07/06/2004 MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) ROCHE DIAGNOSTICS CORP.
K052101 08/03/2005 C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C Roche Diagnostics
K042389 09/02/2004 MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA ROCHE DIAGNOSTICS CORP.
K052464 09/08/2005 TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST ROCHE DIAGNOSTICS CORP.
K042485 09/13/2004 TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) ROCHE DIAGNOSTICS CORP.
K053287 11/25/2005 COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS ROCHE DIAGNOSTICS CORP.
K053289 11/25/2005 COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE DIAGNOSTICS CORP.
K033873 12/15/2003 ELECSYS C-PEPTIDE CALSET ROCHE DIAGNOSTICS CORP.
K033937 12/19/2003 ELECSYS PRECICONTROL MULTIANALYTE ROCHE DIAGNOSTICS CORP.
K053603 12/23/2005 C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS ROCHE DIAGNOSTICS CORP.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact