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FDA 510(k) Application Details - K200010
Device Classification Name
More FDA Info for this Device
510(K) Number
K200010
Device Name
FilmArray BCID2 Control Panel M416
Applicant
Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Saco, ME 04072 US
Other 510(k) Applications for this Company
Contact
Joan Gordon
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PMN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/02/2020
Decision Date
04/02/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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