Medical Device Manufacturer · US , Mchenry , IL

Nova Biomedical Corp.

89 submissions · 89 cleared · Since 1977
89
Total
89
Cleared
0
Denied

Nova Biomedical Corp. — FDA 510(k) Submissions

Nova Biomedical Corp. has submitted 89 FDA 510(k) premarket notifications since 1977, of which 89 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph, Electrode, Ion Specific, Sodium, Multi-analyte Controls, All Kinds (assayed), Electrode, Ion Specific, Calcium, Electrode, Ion Specific, Potassium . Use the specialty filter in the sidebar to narrow results.

89 devices
1–25 of 89
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602 · KHP Acid, Lactic, Enzymatic... · Chemistry
Aug 2011 532d
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
K101633 · JJY Multi-analyte Controls,... · Chemistry
Aug 2010 78d
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
K091547 · NBW System, Test, Blood... · Chemistry
Jan 2010 233d
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
K070960 · CGA Glucose Oxidase, Glucose · Chemistry
Jul 2007 97d
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
K070255 · NBW System, Test, Blood... · Chemistry
Jun 2007 138d
NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
K070068 · CGL Electrode, Ion Based,... · Chemistry
May 2007 119d
NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K063821 · CGA Glucose Oxidase, Glucose · Chemistry
Jan 2007 29d
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
K061830 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Nov 2006 126d
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
K060345 · CGA Glucose Oxidase, Glucose · Chemistry
Apr 2006 77d
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
K041016 · JJX Single (specified)... · Chemistry
May 2004 17d
NOVA GLUCOSE CONTROL SOLUTIONS
K033433 · JJX Single (specified)... · Chemistry
Jan 2004 66d
STAT PROFILE PHOX PLUS L ANALYZER
K023567 · CHL Electrode Measurement,... · Chemistry
Dec 2002 58d
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K022746 · CHL Electrode Measurement,... · Chemistry
Nov 2002 95d
STAT PROFILE PHOX PLUS C ANALYZER
K021713 · CHL Electrode Measurement,... · Chemistry
Jul 2002 63d
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297 · CHL Electrode Measurement,... · Chemistry
Jun 2002 133d
STAT PROFILE PHOX ANALYZER
K014295 · CHL Electrode Measurement,... · Chemistry
Feb 2002 62d
STAT PROFILE PHOX BASIC ANALYZER
K013729 · CHL Electrode Measurement,... · Chemistry
Jan 2002 67d
STAT PROFILE PHOX PLUS L ANALYZER
K012058 · CHL Electrode Measurement,... · Chemistry
Aug 2001 49d
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613 · CHL Electrode Measurement,... · Chemistry
Oct 2000 58d
STATLYTE NA/K/CL/LI ANALYZER
K001761 · JGS Electrode, Ion Specific,... · Chemistry
Aug 2000 59d
STAT PROFILE PHOX PLUS ANALYZER
K000895 · JGS Electrode, Ion Specific,... · Chemistry
Apr 2000 28d
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
K993104 · GLY Oximeter To Measure... · Hematology
Dec 1999 77d
STAT PROFILE M7 ANALYZER
K991727 · CGL Electrode, Ion Based,... · Chemistry
Jul 1999 57d
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K982277 · CHL Electrode Measurement,... · Chemistry
Jul 1998 23d
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
K981425 · GKF Instrument, Hematocrit,... · General & Plastic Surgery
May 1998 26d

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