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Data / Medical devices / United States / Nova Biomedical Corporation

Nova Biomedical Corporation: FDA-registered device maker in Billerica, MA, United States, 18 510(k) clearances

Nova Biomedical Corporation is registered with the FDA (registration 3023162659) in Billerica, MA, United States. It lists 39 device types. The FDA files 18 510(k) clearances under its listings, the newest dated November 22, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Nova Biomedical Corporation
FDA registration number
3023162659
Address
4 Enterprise Road, Billerica, MA, United States, 01821
Owner or operator
NOVA BIOMEDICAL CORP. (1219029)
Roles
Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler
First device listed
October 19, 2007
Registered through
2026
Brand names listed
42035 Prime Sensor Card ES Comp, 52853 Prime ES Comp, 53102 Prime Calibrator Cartridge ES Comp 300 Sample, 53103 Prime Calibrator Cartridge ES Comp 100 Sample, 53110 Prime Ampuled Control ES, 53362 Prime Calibrator Cartridge ES Comp 200 Sample, 53417 Remanufactured Prime ES Comp, 53460 Prime Calibrator Cartridge ES Comp 400 Sample and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Lactic, Enzymatic MethodKHP1Manufacturer, Remanufactureraccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Manufacturer for exportaccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Assay, CarboxyhemoglobinGHS2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Assay, Fetal HemoglobinKQI2Manufacturer for exportaccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Assay, SulfhemoglobinGJC2Manufacturer, Remanufactureraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Manufacturer, Remanufactureraccessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test SystemMQM1Manufacturer for exportaccessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit MeasurementKRZ2Manufacturer for exportaccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Calibrator, Pressure, GasBXX1Manufacturer, Remanufactureraccessdata.fda.gov
Colorimetric Method, TriglyceridesJGY1Manufacturer for exportaccessdata.fda.gov
Controls For Blood-Gases, (Assayed And Unassayed)JJS1Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
CyanomethemoglobinGKK2Manufacturer, Remanufactureraccessdata.fda.gov
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) ClinicaJQT1Manufacturer, Remanufactureraccessdata.fda.gov
Device, Hematocrit MeasuringJPI2Manufacturer, Remanufactureraccessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhCHL2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Electrode, Ion Based, Enzymatic, CreatinineCGL2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Electrode, Ion Specific, CalciumJFP2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Electrode, Ion Specific, MagnesiumCFA1Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Electrode, Ion Specific, Urea NitrogenCDS2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Manufacturer for exportaccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Repackager or relabeleraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Manufacturer, Remanufactureraccessdata.fda.gov
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin ReductionJBJ2Manufacturer for exportaccessdata.fda.gov
Instrument, Hematocrit, AutomatedGKF2Manufacturer, Remanufactureraccessdata.fda.gov
Ldl & Vldl Precipitation, HdlLBR1Manufacturer for exportaccessdata.fda.gov
Mixture, Hematology Quality ControlJPK2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Oximeter To Measure HemoglobinGLY2Manufacturer, Remanufactureraccessdata.fda.gov
OxyhemoglobinGGZ2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Retainer, MatrixJEP1Manufacturer, Remanufactureraccessdata.fda.gov
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-MonoxideJKS1Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Standards And Controls, Hemoglobin, Normal And AbnormalGFS2Manufacturer for exportaccessdata.fda.gov
System, Hemoglobin, AutomatedGKR2Manufacturer, Manufacturer for export, Remanufactureraccessdata.fda.gov
Test, Lactic Acid, Over The CounterNGD1Manufacturer, Remanufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 22, 2024K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCPSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
October 18, 2022K203549Nova Primary Glucose Analyzer SystemCGASubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
August 16, 2019K191626Stat Profile Prime ES Comp Plus Analyzer SystemJFPSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
July 19, 2019K191365Stat Profile Prime ES Comp Plus Analyzer SystemJGSSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
September 26, 2018K180340Stat Profile Prime Plus Analyzer SystemCGASubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
August 23, 2018K180186Stat Profile Prime Plus Analyzer SystemGGZSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
August 15, 2018K180428Stat Profile Prime Plus Analyzer SystemJGSSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
July 17, 2018K173797Stat Profile Prime Plus Analyzer SystemCHLSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
September 10, 2015K151982Stat Profile Prime ABG Analyzer SystemCHLSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
May 29, 2015K141907STAT 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 ACHLSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
October 17, 2014K142220Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)CHLSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
March 25, 2014K131703NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEMCHLSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
August 29, 2011K110648NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEMCHLSubstantially EquivalentNova Biomedical Corporationaccessdata.fda.gov
July 25, 2002K021713STAT PROFILE PHOX PLUS C ANALYZERCHLSubstantially EquivalentNova Biomedical Corp.accessdata.fda.gov
February 28, 2002K014295STAT PROFILE PHOX ANALYZERCHLSubstantially EquivalentNova Biomedical Corp.accessdata.fda.gov
January 15, 2002K013729STAT PROFILE PHOX BASIC ANALYZERCHLSubstantially EquivalentNova Biomedical Corp.accessdata.fda.gov
September 29, 1992K923806ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATERJGSSubstantially EquivalentNova Biomedical Corp.accessdata.fda.gov
July 17, 1992K922215NOVA 14 NA/K/CL/GLU/BUN ANALYZERJGSSubstantially EquivalentNova Biomedical Corp.accessdata.fda.gov

Compare with other makers

Updated November 22, 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.