Nova Biomedical Corporation - FDA 510(k) Cleared Devices
Recent clearances: Nova Max Creat eGFR Monitoring System, Nova Allegro UACR Assay, Nova Allegro Analyzer, Nova Allegro HbA1c Assay, Nova Allegro Analyzer
40
Total
40
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nova Biomedical Corporation Chemistry ✕
40 devices
Cleared
Jan 21, 2026
Nova Max Creat eGFR Monitoring System
Chemistry
272d
Cleared
Jan 09, 2026
Nova Allegro UACR Assay, Nova Allegro Analyzer
Chemistry
179d
Cleared
Nov 22, 2024
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
Chemistry
931d
Cleared
Nov 19, 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
Chemistry
881d
Cleared
Feb 23, 2024
StatStrip Glucose Hospital Meter System
Chemistry
226d
Cleared
Sep 29, 2023
Stat Profile Prime Plus Analyzer System
Chemistry
456d
Cleared
Oct 18, 2022
Nova Primary Glucose Analyzer System
Chemistry
683d
Cleared
Apr 14, 2020
Stat Profile Prime Plus Analyzer System
Chemistry
55d
Cleared
Apr 06, 2020
Stat Profile Prime Plus Analyzer System
Chemistry
69d
Cleared
Mar 13, 2020
Stat Profile Prime Plus Analyzer System
Chemistry
30d
Cleared
Jan 24, 2020
Stat Profile Prime Plus Analyzer System
Chemistry
60d
Cleared
Aug 16, 2019
Stat Profile Prime ES Comp Plus Analyzer System
Chemistry
59d
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