FDA 510(k) Applications Submitted by NOVA BIOMEDICAL CORP.
| 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. |
| K963005 |
08/02/1996 |
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) |
NOVA BIOMEDICAL CORP. |
| K993104 |
09/16/1999 |
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR |
NOVA BIOMEDICAL CORP. |
| K955013 |
11/01/1995 |
NOVA CO-OXIMETER ANALYZER |
NOVA BIOMEDICAL CORP. |
| K955252 |
11/15/1995 |
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4 |
NOVA BIOMEDICAL CORP. |
| K014295 |
12/28/2001 |
STAT PROFILE PHOX ANALYZER |
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. |
| 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. |
| K981425 |
04/16/1998 |
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS |
NOVA BIOMEDICAL CORP. |
| K981426 |
04/16/1998 |
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS |
NOVA BIOMEDICAL CORP. |
| K981427 |
04/16/1998 |
STAT PROFILE M ANALYZER |
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. |
| 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. |
| 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. |
| 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. |
| K955260 |
11/15/1995 |
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION |
NOVA BIOMEDICAL CORP. |
| K955264 |
11/15/1995 |
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 |
NOVA BIOMEDICAL CORP. |
| K070255 |
01/26/2007 |
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 |
NOVA BIOMEDICAL CORP. |
| 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. |
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