Nova Biomedical Corporation FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Nova Max Creat eGFR Monitoring System510(k)Jan 21, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jan 21, 2026
Nova Allegro UACR Assay, Nova Allegro Analyzer510(k)Jan 9, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Dual Track)	Jan 9, 2026
Nova Allegro HbA1c Assay, Nova Allegro Analyzer510(k)Nov 22, 2024Hematology	Hematology	510(k)Substantially Equivalent (Dual Track)	Nov 22, 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer510(k)Nov 19, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Dual Track)	Nov 19, 2024
StatStrip Glucose Hospital Meter System510(k)Feb 23, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Dual Track)	Feb 23, 2024
Stat Profile Prime Plus Analyzer System510(k)Sep 29, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Sep 29, 2023
Nova Primary Glucose Analyzer System510(k)Oct 18, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Oct 18, 2022