ACON Laboratories, Inc. FDA Approvals

0 new drug approvals and 8 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
Flowflex Plus RSV + Flu A/B + COVID Rapid Test510(k)Jul 10, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Jul 10, 2026
Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip510(k)Nov 26, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Nov 26, 2025
Flowflex Plus RSV + Flu A/B + COVID Home Test510(k)Oct 22, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 22, 2025
On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System510(k)Oct 10, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Oct 10, 2025
Flowflex Plus COVID-19 + Flu A/B Home Test510(k)May 10, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	May 10, 2025
Distinct® Digital Pregnancy Test510(k)May 31, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 31, 2024
Flowflex® Plus COVID-19 Home Test510(k)Apr 19, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 19, 2024
Flowflex COVID-19 Antigen Home Test510(k)Nov 9, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Nov 9, 2023