FDA.reportPublic FDA data

510(k) K233611

Device
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
Applicant
Maine Molecular Quality Controls, Inc.
510(k) number
K233611
Product code
PMN
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-26
Date received
2023-11-13
Regulation
866.3920
Classification name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joan Gordon
Address
23 Mill Brook Rd. Saco ME US 04072 04072

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PMN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.2026-05-19
K260041MDx-Chex for BCPStreck, LLC2026-03-27
K254166MDx-Chex for BCNStreck2026-03-23
K254167MDx-Chex for BCYStreck, LLC2026-03-17
K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.2025-08-14
K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.2024-05-30
K231223MDx-Chex for BC-GNStreck2023-07-27
K231221MDx-Chex for BC-GPStreck2023-07-27
K230868SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative ControlMaine Molecular Quality Controls, Inc.2023-04-13
K221253SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.2023-02-03
K203680BioFire JI Control Panel M420Maine Molecular Quality Controls, Inc.2022-07-22
K201403NATtrol BD MAX Vaginal Panel External ControlsZeptometrix2022-02-02
K212576MDx-Chex for BCID2Streck, Inc.2022-01-19
K202196BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc.2021-06-24
K202382FilmArray Global Fever Panel External Control KitBiofire Defense, LLC2020-11-20