FilmArray RP2/RP2plus Control Panel

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 Filmarray Rp2/rp2plus Control Panel.

Pre-market Notification Details

Device IDK173171
510k NumberK173171
Device Name:FilmArray RP2/RP2plus Control Panel
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 Received2017-09-29
Decision Date2017-11-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852720008039 K173171 000

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