FDA 510(k) Application Details - K182467

Device Classification Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test   More FDA Info for this Device
510(K) Number	K182467
Device Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Applicant	DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 US Other 510(k) Applications for this Company
Contact	Sharon Young Other 510(k) Applications for this Contact
Regulation Number	866.3740   More FDA Info for this Regulation Number
Classification Product Code	NJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2018
Decision Date	11/07/2018
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