FDA 510(k) Applications Submitted by SHERRI L COENEN

FDA 510(k) Number Submission Date Device Name Applicant
K020369 02/04/2002 ELECSYS ANTI-TG CALCHECK ROCHE DIAGNOSTICS CORP.
K040264 02/04/2004 CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF ROCHE DIAGNOSTICS CORP.
K040280 02/06/2004 PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS ROCHE DIAGNOSTICS CORP.
K040431 02/19/2004 ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 ROCHE DIAGNOSTICS CORP.
K040434 02/19/2004 ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 ROCHE DIAGNOSTICS CORP.
K040435 02/19/2004 ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 ROCHE DIAGNOSTICS CORP.
K020672 03/01/2002 ELECSYS ANTI-TG TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K030740 03/10/2003 MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K020883 03/18/2002 ELECSYS PROBNP CALCHECK ROCHE DIAGNOSTICS CORP.
K021218 04/17/2002 ELECSYS CORTISOL TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K031756 06/06/2003 ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY ROCHE DIAGNOSTICS CORP.
K031824 06/13/2003 COBAS INTEGRA CHOLESTEROL GEN. 2 ROCHE DIAGNOSTICS CORP.
K031879 06/18/2003 COBAS INTEGRA CARBON DIOXIDE ASSAY ROCHE DIAGNOSTICS CORP.
K031880 06/18/2003 AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL ROCHE DIAGNOSTICS CORP.
K032089 07/07/2003 ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC ROCHE DIAGNOSTICS CORP.
K012286 07/20/2001 MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP.
K012287 07/20/2001 MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP.
K012371 07/26/2001 TINA-QUANT TRANSFERRIN VER.2 ROCHE DIAGNOSTICS CORP.
K012393 07/27/2001 TINA-QUANT TRANSFERRIN VER.2 ROCHE DIAGNOSTICS CORP.
K012399 07/27/2001 MODIFICATION TO ELECSYS FSH II CALSET ROCHE DIAGNOSTICS CORP.
K032336 07/29/2003 TINA-QUANT CRP (LATEX) ROCHE DIAGNOSTICS CORP.
K032377 08/01/2003 ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID ROCHE DIAGNOSTICS CORP.
K022654 08/09/2002 MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB ROCHE DIAGNOSTICS CORP.
K032535 08/18/2003 MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K033009 09/26/2003 ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 ROCHE DIAGNOSTICS CORP.
K033185 10/01/2003 COBAS INTEGRA ALP IFCC GEN.2 ROCHE DIAGNOSTICS CORP.
K033501 11/05/2003 MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) ROCHE DIAGNOSTICS CORP.
K033610 11/17/2003 HDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP.
K024098 12/12/2002 COBAS INTEGRA CREATININE PLUS VER.2 ASSAY ROCHE DIAGNOSTICS CORP.


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