Nova Biomedical Corporation
FDA 510(k) & PMA Approved Devices — 27 products
Total Devices27
Categories12
Latest Approval2026-01-21
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251281 | Nova Max Creat eGFR Monitoring System | SHB | 2026-01-21 | View |
| 510(k) | K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | 2026-01-09 | View |
| 510(k) | K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | LCP | 2024-11-22 | View |
| 510(k) | K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | 2024-11-19 | View |
| 510(k) | K232075 | StatStrip Glucose Hospital Meter System | PZI | 2024-02-23 | View |
| 510(k) | K221900 | Stat Profile Prime Plus Analyzer System | CHL | 2023-09-29 | View |
| 510(k) | K203549 | Nova Primary Glucose Analyzer System | CGA | 2022-10-18 | View |
| 510(k) | K200403 | Stat Profile Prime Plus Analyzer System | JGS | 2020-04-14 | View |
| 510(k) | K200204 | Stat Profile Prime Plus Analyzer System | GGZ | 2020-04-06 | View |
| 510(k) | K200349 | Stat Profile Prime Plus Analyzer System | CGA | 2020-03-13 | View |
| 510(k) | K193246 | Stat Profile Prime Plus Analyzer System | CHL | 2020-01-24 | View |
| 510(k) | K191626 | Stat Profile Prime ES Comp Plus Analyzer System | JFP | 2019-08-16 | View |
| 510(k) | K191365 | Stat Profile Prime ES Comp Plus Analyzer System | JGS | 2019-07-19 | View |
| 510(k) | K182552 | StatStrip Xpress Glucose Hospital Meter System | PZI | 2018-12-13 | View |
| 510(k) | K182549 | StatStrip Xpress 2 Glucose Hospital Meter System | PZI | 2018-12-13 | View |
| 510(k) | K180340 | Stat Profile Prime Plus Analyzer System | CGA | 2018-09-26 | View |
| 510(k) | K180186 | Stat Profile Prime Plus Analyzer System | GGZ | 2018-08-23 | View |
| 510(k) | K180428 | Stat Profile Prime Plus Analyzer System | JGS | 2018-08-15 | View |
| 510(k) | K173797 | Stat Profile Prime Plus Analyzer System | CHL | 2018-07-17 | View |
| 510(k) | K181043 | StatStrip Glucose Hospital Meter System | PZI | 2018-07-12 | View |
| 510(k) | K170464 | StatStrip Xpress Blood Glucose Monitoring System | NBW | 2017-11-07 | View |
| 510(k) | K171059 | Nova StatSensor Creatinine Hospital Meter System | CGL | 2017-05-26 | View |
| 510(k) | K160990 | Nova Max Uric Acid Monitoring System | PTC | 2017-04-11 | View |
| 510(k) | K163490 | StatStrip Xpress 2 Glucose Hospital Meter System | PZI | 2017-01-06 | View |
| 510(k) | K161856 | StatStrip Xpress Glucose Hospital Meter System | PZI | 2016-11-15 | View |
| 510(k) | K160156 | StatStrip Xpress Blood Glucose Monitoring System | NBW | 2016-06-23 | View |
| 510(k) | K152986 | StatStrip Xpress 2 Glucose Hospital Meter System | PZI | 2016-01-27 | View |
No matching devices.