BioFire RP2.1/RP2.1plus Control Panel M441

Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

Maine Molecular Quality Controls, Inc.

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.

Pre-market Notification Details

Device IDK202196
510k NumberK202196
Device Name:BioFire RP2.1/RP2.1plus Control Panel M441
ClassificationAssayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Applicant Maine Molecular Quality Controls, Inc. 23 Mill Brook Road Saco,  ME  04072
ContactJoan Gordon
CorrespondentJoan Gordon
Maine Molecular Quality Controls, Inc. 23 Mill Brook Road Saco,  ME  04072
Product CodePMN  
CFR Regulation Number866.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-05
Decision Date2021-06-24

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