Maine Molecular Quality Controls, 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
FilmArray TF Control Panel M527510(k)May 19, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	May 19, 2026
FilmArray GI Control Panel M238510(k)Aug 14, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Aug 14, 2025
SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control510(k)May 30, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	May 30, 2024
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)510(k)Mar 26, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 26, 2024
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control510(k)Apr 13, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Apr 13, 2023
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control510(k)Feb 3, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Feb 3, 2023
BioFire JI Control Panel M420510(k)Jul 22, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 22, 2022
BioFire RP2.1/RP2.1plus Control Panel M441510(k)Jun 24, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jun 24, 2021