FDA 510(k) Applications Submitted by MIKE FLIS

FDA 510(k) Number Submission Date Device Name Applicant
K070189 01/22/2007 ACCU-CHEK ULTRAFLEX INFUSION SET DISETRONIC MEDICAL SYSTEMS AG
K000364 02/04/2000 ACCU-CHEK COMPLETE METER ROCHE DIAGNOSTICS CORP.
K000365 02/04/2000 ACCU-CHEK ADVANTAGE METER ROCHE DIAGNOSTICS CORP.
K010362 02/06/2001 ACCU-CHEK COMFORT CURVE TEST STRIP ROCHE DIAGNOSTICS CORP.
K030428 02/10/2003 ROCHE ONLINE TDM PHENYTOIN ROCHE DIAGNOSTICS CORP.
K980731 02/25/1998 ACCU-CHEK COMFORT CURVE TEST STRIPS BOEHRINGER MANNHEIM CORP.
K020704 03/04/2002 ROCHE ONLINE GENTAMICIN ROCHE DIAGNOSTICS CORP.
K020740 03/06/2002 ROCHE ONLINE THEOPHYLLINE ROCHE DIAGNOSTICS CORP.
K951331 03/24/1995 ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR BOEHRINGER MANNHEIM CORP.
K021448 05/06/2002 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM ROCHE DIAGNOSTICS CORP.
K021827 06/04/2002 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM ROCHE DIAGNOSTICS CORP.
K011738 06/05/2001 ACCU-CHEK ACTIVE SYSTEM ROCHE DIAGNOSTICS CORP.
K121679 06/07/2012 ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics
K982002 06/08/1998 ACCU-CHEK COMFORT CURVE TEST STRIP BOEHRINGER MANNHEIM CORP.
K982079 06/15/1998 ACCU-CHECK VOICEMATE BOEHRINGER MANNHEIM CORP.
K982089 06/15/1998 ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS BOEHRINGER MANNHEIM CORP.
K942884 06/17/1994 COAGUCHEK SYSTEM BOEHRINGER MANNHEIM CORP.
K001907 06/22/2000 CAMIT DIABETES MANAGEMENT SOFTWARE ROCHE DIAGNOSTICS CORP.
K032049 07/02/2003 ROCHE ONLINE TDM VALPROIC ACID ROCHE DIAGNOSTICS CORP.
K012210 07/16/2001 MODIFICATION TO ACCU-CHEK INFORM METER ROCHE DIAGNOSTICS CORP.
K012324 07/23/2001 ACCU-CHEK ACTIVE TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K032332 07/29/2003 ROCHE ONLINE TDM QUINIDINE ROCHE DIAGNOSTICS CORP.
K032334 07/29/2003 ROCHE ONLINE TDM LIDOCAINE ROCHE DIAGNOSTICS CORP.
K972876 08/04/1997 GLUCOTREND BASIC SYSTEM BOEHRINGER MANNHEIM CORP.
K983047 09/01/1998 ACCU-CHEK HQ SYSTEM BOEHRINGER MANNHEIM CORP.
K944458 09/12/1994 ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST BOEHRINGER MANNHEIM CORP.
K944459 09/12/1994 ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM BOEHRINGER MANNHEIM CORP.
K973523 09/17/1997 ACCUSTAT H. PYLORI ONE STEP TEST BOEHRINGER MANNHEIM CORP.
K973662 09/25/1997 ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS BOEHRINGER MANNHEIM CORP.
K993829 11/12/1999 ACCU-CHEK SIMPLICITY SYSTEM ROCHE DIAGNOSTICS CORP.
K013757 11/13/2001 ROCHE ACETAMINOPHEN ROCHE DIAGNOSTICS CORP.
K974491 11/28/1997 ACCU-CHEK A1C HEMOGLOBIN TEST BOEHRINGER MANNHEIM CORP.
K003846 12/12/2000 ACCU-CHEK INFORM METER ROCHE DIAGNOSTICS CORP.


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