Data / Medical devices / United States / Nova Biomedical Corporation
Nova Biomedical Corporation: FDA-registered device maker in Billerica, MA, United States, 20 510(k) clearances
Nova Biomedical Corporation is registered with the FDA (registration 3011979858) in Billerica, MA, United States. It lists 13 device types. The FDA files 20 510(k) clearances under its listings, the newest dated February 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011979858
- Address
- 165 Lexington Rd, Billerica, MA, United States, 01821
- Owner or operator
- NOVA BIOMEDICAL CORP. (1219029)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer
- First device listed
- January 31, 2007
- Registered through
- 2026
- Brand names listed
- 51184 Menarini Glucofix Mio Premium, 51185 Menarini Glucofix Mio Premium, Focus, Focus Pro, LifeScan OneTouch StatStrip, Menarini Glucomen Lx, Menarini GlycoPC, Nipro StatStrip XP3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Lactic, Enzymatic Method | KHP | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Electrode, Ion Based, Enzymatic, Creatinine | CGL | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Manufacturer for export | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer | accessdata.fda.gov |
| Hemoglobinometer | GIG | 2 | Manufacturer for export | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Contract manufacturer, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Contract manufacturer, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Oximeter To Measure Hemoglobin | GLY | 2 | Manufacturer for export | accessdata.fda.gov |
| Prescription Use Blood Glucose Meter For Near-Patient Testing | PZI | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer | accessdata.fda.gov |
| Uric Acid Test System For At Home Prescription Use | PTC | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2024 | K232075 | StatStrip Glucose Hospital Meter System | PZI | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| April 11, 2017 | K160990 | Nova Max Uric Acid Monitoring System | PTC | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| June 23, 2016 | K160156 | StatStrip Xpress Blood Glucose Monitoring System | NBW | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| January 27, 2016 | K152986 | StatStrip Xpress 2 Glucose Hospital Meter System | PZI | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| May 20, 2015 | K150461 | StatStrip Xpress Glucose Hospital Meter System | PZI | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| May 6, 2015 | K150281 | StatStrip Glucose Hospital Meter | PZI | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| September 24, 2014 | K132121 | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | PZI | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| October 17, 2013 | K131013 | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| April 4, 2013 | K122688 | NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR | LFR | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| December 20, 2012 | K122435 | NOVA ONE BLOOD GLUCOSE MONITOR | LFR | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| March 9, 2012 | K112638 | NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS | NBW | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| January 5, 2012 | K112955 | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM | KHP | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| August 17, 2011 | K100602 | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS | KHP | Substantially Equivalent | Nova Biomedical Corp. | accessdata.fda.gov |
| January 15, 2010 | K091547 | NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS | NBW | Substantially Equivalent | Nova Biomedical Corp. | accessdata.fda.gov |
| July 11, 2007 | K070960 | NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM | CGA | Substantially Equivalent | Nova Biomedical Corp. | accessdata.fda.gov |
| June 13, 2007 | K070255 | NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 | NBW | Substantially Equivalent | Nova Biomedical Corp. | accessdata.fda.gov |
| May 7, 2007 | K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | CGL | Substantially Equivalent | Nova Biomedical Corp. | accessdata.fda.gov |
| January 24, 2007 | K063821 | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | CGA | Substantially Equivalent | Nova Biomedical Corp. | accessdata.fda.gov |
| April 28, 2006 | K060345 | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS | CGA | Substantially Equivalent | Nova Biomedical Corp. | accessdata.fda.gov |
| May 19, 2004 | K040603 | PARADIGM LINK BLOOD GLUCOSE METER | NBW | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
Compare with other makers
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
- All makers of Acid, Lactic, Enzymatic Method
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Oxidase, Glucose
- All makers of Glucose Dehydrogenase, Glucose
Updated February 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.