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Nova Biomedical Corporation

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories12
Latest FDA decision2026-01-21
TypeNumberDevice NameCodeDateActions
510(k) K251281 Nova Max Creat eGFR Monitoring SystemSHB2026-01-21 View
510(k) K252206 Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX2026-01-09 View
510(k) K221326 Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP2024-11-22 View
510(k) K221813 Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX2024-11-19 View
510(k) K232075 StatStrip Glucose Hospital Meter SystemPZI2024-02-23 View
510(k) K221900 Stat Profile Prime Plus Analyzer SystemCHL2023-09-29 View
510(k) K203549 Nova Primary Glucose Analyzer SystemCGA2022-10-18 View
510(k) K200403 Stat Profile Prime Plus Analyzer SystemJGS2020-04-14 View
510(k) K200204 Stat Profile Prime Plus Analyzer SystemGGZ2020-04-06 View
510(k) K200349 Stat Profile Prime Plus Analyzer SystemCGA2020-03-13 View
510(k) K193246 Stat Profile Prime Plus Analyzer SystemCHL2020-01-24 View
510(k) K191626 Stat Profile Prime ES Comp Plus Analyzer SystemJFP2019-08-16 View
510(k) K191365 Stat Profile Prime ES Comp Plus Analyzer SystemJGS2019-07-19 View
510(k) K182552 StatStrip Xpress Glucose Hospital Meter SystemPZI2018-12-13 View
510(k) K182549 StatStrip Xpress 2 Glucose Hospital Meter SystemPZI2018-12-13 View
510(k) K180340 Stat Profile Prime Plus Analyzer SystemCGA2018-09-26 View
510(k) K180186 Stat Profile Prime Plus Analyzer SystemGGZ2018-08-23 View
510(k) K180428 Stat Profile Prime Plus Analyzer SystemJGS2018-08-15 View
510(k) K173797 Stat Profile Prime Plus Analyzer SystemCHL2018-07-17 View
510(k) K181043 StatStrip Glucose Hospital Meter SystemPZI2018-07-12 View

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