FDA.reportPublic FDA data

510(k) K230868

Device
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
Applicant
Maine Molecular Quality Controls, Inc.
510(k) number
K230868
Product code
PMN
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-13
Date received
2023-03-29
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
Special
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
K233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)Maine Molecular Quality Controls, Inc.2024-03-26
K231223MDx-Chex for BC-GNStreck2023-07-27
K231221MDx-Chex for BC-GPStreck2023-07-27
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