FilmArray BCID2 Control Panel M416

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 Bcid2 Control Panel M416.

Pre-market Notification Details

Device IDK200010
510k NumberK200010
Device Name:FilmArray BCID2 Control Panel M416
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 Received2020-01-02
Decision Date2020-04-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852720008077 K200010 000

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