FDA 510(k) Application Details - K181436

Device Classification Name	System, Test, Infectious Mononucleosis   More FDA Info for this Device
510(K) Number	K181436
Device Name	System, Test, Infectious Mononucleosis
Applicant	Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Shelly Harris Other 510(k) Applications for this Contact
Regulation Number	866.5640   More FDA Info for this Regulation Number
Classification Product Code	KTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2018
Decision Date	06/22/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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