FDA 510(k) Application Details - K191352

Device Classification Name	More FDA Info for this Device
510(K) Number	K191352
Device Name	binx health io CT/NG Assay
Applicant	binx health, Inc. 77 N. Washington Street, 5th Floor Boston, MA 02114 US Other 510(k) Applications for this Company
Contact	Sarah Kalil Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2019
Decision Date	08/08/2019
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