510(k) K202196
- Device
- BioFire RP2.1/RP2.1plus Control Panel M441
- Applicant
- Maine Molecular Quality Controls, Inc.
- 510(k) number
- K202196
- Product code
- PMN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-06-24
- Date received
- 2020-08-05
- 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#
- 2024674
- 2016706
- 2024800
- 1950302
- 2150138
- 3005959679
- 1528450
- 2023365
- 3010127294
- 3010770794
Source Documents#
Other 510(k) Records For Product Code PMN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | 2026-05-19 |
| K260041 | MDx-Chex for BCP | Streck, LLC | 2026-03-27 |
| K254166 | MDx-Chex for BCN | Streck | 2026-03-23 |
| K254167 | MDx-Chex for BCY | Streck, LLC | 2026-03-17 |
| K251526 | FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. | 2025-08-14 |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2024-05-30 |
| K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) | Maine Molecular Quality Controls, Inc. | 2024-03-26 |
| K231223 | MDx-Chex for BC-GN | Streck | 2023-07-27 |
| K231221 | MDx-Chex for BC-GP | Streck | 2023-07-27 |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2023-04-13 |
| K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2023-02-03 |
| K203680 | BioFire JI Control Panel M420 | Maine Molecular Quality Controls, Inc. | 2022-07-22 |
| K201403 | NATtrol BD MAX Vaginal Panel External Controls | Zeptometrix | 2022-02-02 |
| K212576 | MDx-Chex for BCID2 | Streck, Inc. | 2022-01-19 |
| K202382 | FilmArray Global Fever Panel External Control Kit | Biofire Defense, LLC | 2020-11-20 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases