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Nova Biomedical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
89
Inspections
0
Compliance Actions
0

Known Names

nova biomedical corporation, nova biomedical

Recent 510(k) Clearances

K-NumberDeviceDate
K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSAugust 17, 2011
K101633NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGHAugust 27, 2010
K091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NJanuary 15, 2010
K070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEMJuly 11, 2007
K070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002June 13, 2007
K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSMay 7, 2007
K063821NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEMJanuary 24, 2007
K061830STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+November 1, 2006
K060345NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONSApril 28, 2006
K041016NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONSMay 7, 2004
K033433NOVA GLUCOSE CONTROL SOLUTIONSJanuary 2, 2004
K023567STAT PROFILE PHOX PLUS L ANALYZERDecember 20, 2002
K022746STAT PROFILE CRITICAL CARE XPRESS ANALYZERNovember 22, 2002
K021713STAT PROFILE PHOX PLUS C ANALYZERJuly 25, 2002
K020297STAT PROFILE CRITICAL CARE XPRESS ANALYZERJune 10, 2002
K014295STAT PROFILE PHOX ANALYZERFebruary 28, 2002
K013729STAT PROFILE PHOX BASIC ANALYZERJanuary 15, 2002
K012058STAT PROFILE PHOX PLUS L ANALYZERAugust 20, 2001
K002613MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZEROctober 19, 2000
K001761STATLYTE NA/K/CL/LI ANALYZERAugust 7, 2000