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FDA 510(k) Application Details - K221253
Device Classification Name
More FDA Info for this Device
510(K) Number
K221253
Device Name
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
Applicant
Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Saco, ME 04072 US
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Contact
Joan Gordon
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PMN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/02/2022
Decision Date
02/03/2023
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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