Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

89 results for "Nova Biomedical Corp."
1–24 of 89
Search insights Median review: 71d Cleared: 100% Top manufacturer: Nova Biomedical Corp. Lead specialty: Chemistry
Cleared Aug 17, 2011
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602 · KHP
Nova Biomedical Corp.
Chemistry · 532d
Cleared Aug 27, 2010
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
K101633 · JJY
Nova Biomedical Corp.
Chemistry · 78d
Cleared Jan 15, 2010
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS...
K091547 · NBW
Nova Biomedical Corp.
Chemistry · 233d
Cleared Jul 11, 2007
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
K070960 · CGA
Nova Biomedical Corp.
Chemistry · 97d
Cleared Jun 13, 2007
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
K070255 · NBW
Nova Biomedical Corp.
Chemistry · 138d
Cleared May 07, 2007
NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY...
K070068 · CGL
Nova Biomedical Corp.
Chemistry · 119d
Cleared Jan 24, 2007
NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K063821 · CGA
Nova Biomedical Corp.
Chemistry · 29d
Cleared Nov 01, 2006
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
K061830 · CIG
Nova Biomedical Corp.
Chemistry · 126d
Cleared Apr 28, 2006
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
K060345 · CGA
Nova Biomedical Corp.
Chemistry · 77d
Cleared May 07, 2004
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
K041016 · JJX
Nova Biomedical Corp.
Chemistry · 17d
Cleared Jan 02, 2004
NOVA GLUCOSE CONTROL SOLUTIONS
K033433 · JJX
Nova Biomedical Corp.
Chemistry · 66d
Cleared Dec 20, 2002
STAT PROFILE PHOX PLUS L ANALYZER
K023567 · CHL
Nova Biomedical Corp.
Chemistry · 58d
Cleared Nov 22, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K022746 · CHL
Nova Biomedical Corp.
Chemistry · 95d
Cleared Jul 25, 2002
STAT PROFILE PHOX PLUS C ANALYZER
K021713 · CHL
Nova Biomedical Corp.
Chemistry · 63d
Cleared Jun 10, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297 · CHL
Nova Biomedical Corp.
Chemistry · 133d
Cleared Feb 28, 2002
STAT PROFILE PHOX ANALYZER
K014295 · CHL
Nova Biomedical Corp.
Chemistry · 62d
Cleared Jan 15, 2002
STAT PROFILE PHOX BASIC ANALYZER
K013729 · CHL
Nova Biomedical Corp.
Chemistry · 67d
Cleared Aug 20, 2001
STAT PROFILE PHOX PLUS L ANALYZER
K012058 · CHL
Nova Biomedical Corp.
Chemistry · 49d
Cleared Oct 19, 2000
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613 · CHL
Nova Biomedical Corp.
Chemistry · 58d
Cleared Aug 07, 2000
STATLYTE NA/K/CL/LI ANALYZER
K001761 · JGS
Nova Biomedical Corp.
Chemistry · 59d
Cleared Apr 17, 2000
STAT PROFILE PHOX PLUS ANALYZER
K000895 · JGS
Nova Biomedical Corp.
Chemistry · 28d
Cleared Dec 02, 1999
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1...
K993104 · GLY
Nova Biomedical Corp.
Hematology · 77d
Cleared Jul 16, 1999
STAT PROFILE M7 ANALYZER
K991727 · CGL
Nova Biomedical Corp.
Chemistry · 57d
Cleared Jul 22, 1998
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K982277 · CHL
Nova Biomedical Corp.
Chemistry · 23d