Medical Device Manufacturer · US , Waltham , MA

Nova Biomedical Corporation

40 submissions · 40 cleared · Since 2011
40
Total
40
Cleared
0
Denied

Nova Biomedical Corporation — FDA 510(k) Submissions

Nova Biomedical Corporation has submitted 40 FDA 510(k) premarket notifications since 2011, of which 40 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prescription Use Blood Glucose Meter For Near-patient Testing, Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph, System, Test, Blood Glucose, Over The Counter, Glucose Oxidase, Glucose, Electrode, Ion Specific, Sodium . Use the specialty filter in the sidebar to narrow results.

40 devices
1–25 of 40
Nova Max Creat eGFR Monitoring System
K251281 · SHB Creatinine Test System... · Chemistry
Jan 2026 272d
Nova Allegro UACR Assay, Nova Allegro Analyzer
K252206 · CGX Alkaline Picrate,... · Chemistry
Jan 2026 179d
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
K221326 · LCP Assay, Glycosylated... · Chemistry
Nov 2024 931d
Nova Allegro UACR Assay, Nova Allegro Analyzer
K221813 · CGX Alkaline Picrate,... · Chemistry
Nov 2024 881d
StatStrip Glucose Hospital Meter System
K232075 · PZI Prescription Use Blood... · Chemistry
Feb 2024 226d
Stat Profile Prime Plus Analyzer System
K221900 · CHL Electrode Measurement,... · Chemistry
Sep 2023 456d
Nova Primary Glucose Analyzer System
K203549 · CGA Glucose Oxidase, Glucose · Chemistry
Oct 2022 683d
Stat Profile Prime Plus Analyzer System
K200403 · JGS Electrode, Ion Specific,... · Chemistry
Apr 2020 55d
Stat Profile Prime Plus Analyzer System
K200204 · GGZ Oxyhemoglobin · Chemistry
Apr 2020 69d
Stat Profile Prime Plus Analyzer System
K200349 · CGA Glucose Oxidase, Glucose · Chemistry
Mar 2020 30d
Stat Profile Prime Plus Analyzer System
K193246 · CHL Electrode Measurement,... · Chemistry
Jan 2020 60d
Stat Profile Prime ES Comp Plus Analyzer System
K191626 · JFP Electrode, Ion Specific,... · Chemistry
Aug 2019 59d
Stat Profile Prime ES Comp Plus Analyzer System
K191365 · JGS Electrode, Ion Specific,... · Chemistry
Jul 2019 58d
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · PZI Prescription Use Blood... · Chemistry
Dec 2018 87d
StatStrip Xpress Glucose Hospital Meter System
K182552 · PZI Prescription Use Blood... · Chemistry
Dec 2018 87d
Stat Profile Prime Plus Analyzer System
K180340 · CGA Glucose Oxidase, Glucose · Chemistry
Sep 2018 231d
Stat Profile Prime Plus Analyzer System
K180186 · GGZ Oxyhemoglobin · Chemistry
Aug 2018 212d
Stat Profile Prime Plus Analyzer System
K180428 · JGS Electrode, Ion Specific,... · Chemistry
Aug 2018 180d
Stat Profile Prime Plus Analyzer System
K173797 · CHL Electrode Measurement,... · Chemistry
Jul 2018 215d
StatStrip Glucose Hospital Meter System
K181043 · PZI Prescription Use Blood... · Chemistry
Jul 2018 84d
StatStrip Xpress Blood Glucose Monitoring System
K170464 · NBW System, Test, Blood... · Chemistry
Nov 2017 265d
Nova StatSensor Creatinine Hospital Meter System
K171059 · CGL Electrode, Ion Based,... · Chemistry
May 2017 46d
Nova Max Uric Acid Monitoring System
K160990 · PTC Uric Acid Test System For... · Chemistry
Apr 2017 368d
StatStrip Xpress 2 Glucose Hospital Meter System
K163490 · PZI Prescription Use Blood... · Chemistry
Jan 2017 25d
StatStrip Xpress Glucose Hospital Meter System
K161856 · PZI Prescription Use Blood... · Chemistry
Nov 2016 132d
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