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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
510(k) Number K202196
Device Name BioFire RP2.1/RP2.1plus Control Panel M441
Applicant
Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Saco,  ME  04072
Applicant Contact Joan Gordon
Correspondent
Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Saco,  ME  04072
Correspondent Contact Joan Gordon
Regulation Number866.3920
Classification Product Code
PMN  
Date Received08/05/2020
Decision Date 06/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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