Nova Biomedical Corporation - FDA 510(k) Cleared Devices
40
Total
40
Cleared
0
Denied
40 devices
Cleared
Jun 23, 2016
StatStrip Xpress Blood Glucose Monitoring System
Chemistry
153d
Cleared
Jan 27, 2016
StatStrip Xpress 2 Glucose Hospital Meter System
Chemistry
110d
Cleared
Sep 10, 2015
Stat Profile Prime ABG Analyzer System
Chemistry
55d
Cleared
May 29, 2015
STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE...
Chemistry
318d
Cleared
May 20, 2015
StatStrip Xpress Glucose Hospital Meter System
Chemistry
86d
Cleared
May 06, 2015
StatStrip Glucose Hospital Meter
Chemistry
90d
Cleared
Oct 17, 2014
Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
Chemistry
66d
Cleared
Sep 24, 2014
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Chemistry
441d
Cleared
Mar 25, 2014
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
Chemistry
287d
Cleared
Oct 17, 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
189d
Cleared
Apr 04, 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
Chemistry
212d
Cleared
Dec 20, 2012
NOVA ONE BLOOD GLUCOSE MONITOR
Chemistry
132d
Cleared
Mar 09, 2012
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
Chemistry
182d
Cleared
Jan 05, 2012
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
Chemistry
93d
Cleared
Aug 29, 2011
NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
Chemistry
178d