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FDA 510(k)

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

K-Number: K202196 · 2021-06-24

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2021-06-24
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioFire RP2.1/RP2.1plus Control Panel M441 is a medical device manufactured by Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2021-06-24 under approval number K202196. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioFire RP2.1/RP2.1plus Control Panel M441?

BioFire RP2.1/RP2.1plus Control Panel M441 is a medical device that received FDA 510(k) clearance on 2021-06-24. It is manufactured by Maine Molecular Quality Controls, Inc.. The 510(k) number is K202196.

When was BioFire RP2.1/RP2.1plus Control Panel M441 approved by the FDA?

BioFire RP2.1/RP2.1plus Control Panel M441 received FDA 510(k) clearance on 2021-06-24, under approval number K202196.

What company makes BioFire RP2.1/RP2.1plus Control Panel M441?

BioFire RP2.1/RP2.1plus Control Panel M441 is manufactured by Maine Molecular Quality Controls, Inc..

What is the FDA product code for BioFire RP2.1/RP2.1plus Control Panel M441?

The FDA product code for BioFire RP2.1/RP2.1plus Control Panel M441 is PMN.

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Other Devices by Maine Molecular Quality Controls, Inc.

K161573FilmArray RP EZ Control Panel M265 K173171FilmArray RP2/RP2plus Control Panel K163522FilmArray Warrior Control Panel M290 K190222FilmArray Pneumonia/Pneumoniaplus Control K200010FilmArray BCID2 Control Panel M416 K203680BioFire JI Control Panel M420

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Related Devices (Code: PMN)

K161573FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. K152679Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPakBio-Rad Laboratories DEN150058Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPakBio-Rad Laboratories K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. K182472Cepheid Xpert GBS LB Control PanelMicrobiologics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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