FDA 510(k) Applications Submitted by PAUL W MACDONALD,PHD

FDA 510(k) Number Submission Date Device Name Applicant
K091547 05/27/2009 NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS NOVA BIOMEDICAL CORP.
K960120 01/11/1996 STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS NOVA BIOMEDICAL CORP.
K020297 01/28/2002 STAT PROFILE CRITICAL CARE XPRESS ANALYZER NOVA BIOMEDICAL CORP.
K060345 02/10/2006 NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS NOVA BIOMEDICAL CORP.
K970710 02/26/1997 STAT PROFILE ULTRA M ANALYZER NOVA BIOMEDICAL CORP.
K100602 03/03/2010 NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS NOVA BIOMEDICAL CORP.
K110648 03/04/2011 NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM NOVA BIOMEDICAL CORPORATION
K980991 03/17/1998 NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER NOVA BIOMEDICAL CORP.
K000895 03/20/2000 STAT PROFILE PHOX PLUS ANALYZER NOVA BIOMEDICAL CORP.
K070960 04/05/2007 NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORP.
K981427 04/16/1998 STAT PROFILE M ANALYZER NOVA BIOMEDICAL CORP.
K981426 04/16/1998 STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS NOVA BIOMEDICAL CORP.
K981425 04/16/1998 STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS NOVA BIOMEDICAL CORP.
K041016 04/20/2004 NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS NOVA BIOMEDICAL CORP.
K961938 05/20/1996 STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS NOVA BIOMEDICAL CORP.
K991727 05/20/1999 STAT PROFILE M7 ANALYZER NOVA BIOMEDICAL CORP.
K021713 05/23/2002 STAT PROFILE PHOX PLUS C ANALYZER NOVA BIOMEDICAL CORP.
K001761 06/09/2000 STATLYTE NA/K/CL/LI ANALYZER NOVA BIOMEDICAL CORP.
K101633 06/10/2010 NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH NOVA BIOMEDICAL CORP.
K061830 06/28/2006 STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ NOVA BIOMEDICAL CORP.
K982277 06/29/1998 MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) NOVA BIOMEDICAL CORP.
K012058 07/02/2001 STAT PROFILE PHOX PLUS L ANALYZER NOVA BIOMEDICAL CORP.
K141907 07/15/2014 STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A NOVA BIOMEDICAL CORPORATION
K151982 07/17/2015 Stat Profile Prime ABG Analyzer System NOVA BIOMEDICAL CORPORATION
K962982 08/01/1996 NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT NOVA BIOMEDICAL CORP.
K962997 08/02/1996 NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 NOVA BIOMEDICAL CORP.
K122435 08/10/2012 NOVA ONE BLOOD GLUCOSE MONITOR NOVA BIOMEDICAL CORPORATION
K022746 08/19/2002 STAT PROFILE CRITICAL CARE XPRESS ANALYZER NOVA BIOMEDICAL CORP.
K002613 08/22/2000 MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER NOVA BIOMEDICAL CORP.
K122688 09/04/2012 NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR NOVA BIOMEDICAL CORPORATION
K112638 09/09/2011 NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS NOVA BIOMEDICAL CORPORATION
K112955 10/04/2011 NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORPORATION
K023567 10/23/2002 STAT PROFILE PHOX PLUS L ANALYZER NOVA BIOMEDICAL CORP.
K033433 10/28/2003 NOVA GLUCOSE CONTROL SOLUTIONS NOVA BIOMEDICAL CORP.
K013729 11/09/2001 STAT PROFILE PHOX BASIC ANALYZER NOVA BIOMEDICAL CORP.
K955264 11/15/1995 NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 NOVA BIOMEDICAL CORP.
K955260 11/15/1995 NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION NOVA BIOMEDICAL CORP.
K070255 01/26/2007 NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 NOVA BIOMEDICAL CORP.
K131013 04/11/2013 FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM NOVA BIOMEDICAL CORPORATION
K132121 07/10/2013 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORPORATION
K063821 12/26/2006 NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORP.
K070068 01/08/2007 NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS NOVA BIOMEDICAL CORP.
K150281 02/05/2015 StatStrip Glucose Hospital Meter NOVA BIOMEDICAL CORPORATION
K150461 02/23/2015 StatStrip Xpress Glucose Hospital Meter System NOVA BIOMEDICAL CORPORATION
K171059 04/10/2017 Nova StatSensor Creatinine Hospital Meter System Nova Biomedical Corporation
K161856 07/06/2016 StatStrip Xpress Glucose Hospital Meter System Nova Biomedical Corporation
K142220 08/12/2014 Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) NOVA BIOMEDICAL CORPORATION
K152986 10/09/2015 StatStrip Xpress 2 Glucose Hospital Meter System NOVA BIOMEDICAL CORPORATION
K163490 12/12/2016 StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation


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