The following data is part of a premarket notification filed by Maine Molecular Quality Controls, Inc. with the FDA for Biofire Rp2.1/rp2.1plus Control Panel M441.
| Device ID | K202196 |
| 510k Number | K202196 |
| Device Name: | BioFire RP2.1/RP2.1plus Control Panel M441 |
| Classification | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Applicant | Maine Molecular Quality Controls, Inc. 23 Mill Brook Road Saco, ME 04072 |
| Contact | Joan Gordon |
| Correspondent | Joan Gordon Maine Molecular Quality Controls, Inc. 23 Mill Brook Road Saco, ME 04072 |
| Product Code | PMN |
| CFR Regulation Number | 866.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-05 |
| Decision Date | 2021-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852720008114 | K202196 | 000 |