FDA 510(k) Applications Submitted by Nova Biomedical Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K180186 01/23/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation
K180340 02/07/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation
K180428 02/16/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation
K173797 12/14/2017 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation
K191365 05/22/2019 Stat Profile Prime ES Comp Plus Analyzer System Nova Biomedical Corporation
K191626 06/18/2019 Stat Profile Prime ES Comp Plus Analyzer System Nova Biomedical Corporation
K160156 01/22/2016 StatStrip Xpress Blood Glucose Monitoring System NOVA BIOMEDICAL CORPORATION
K170464 02/15/2017 StatStrip Xpress Blood Glucose Monitoring System Nova Biomedical Corporation
K160990 04/08/2016 Nova Max Uric Acid Monitoring System NOVA BIOMEDICAL CORPORATION
K181043 04/19/2018 StatStrip Glucose Hospital Meter System Nova Biomedical Corporation
K182549 09/17/2018 StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation
K182552 09/17/2018 StatStrip Xpress Glucose Hospital Meter System Nova Biomedical Corporation
K110648 03/04/2011 NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM NOVA BIOMEDICAL CORPORATION
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
K122435 08/10/2012 NOVA ONE BLOOD GLUCOSE MONITOR NOVA BIOMEDICAL CORPORATION
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
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
K131703 06/11/2013 NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM NOVA BIOMEDICAL CORPORATION
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
K200204 01/28/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation
K200349 02/12/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation
K200403 02/19/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation
K193246 11/25/2019 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation
K203549 12/04/2020 Nova Primary Glucose Analyzer System Nova Biomedical Corporation
K221900 06/30/2022 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation


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