FDA 510(k) Application Details - K170652

Device Classification Name	More FDA Info for this Device
510(K) Number	K170652
Device Name	ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
Applicant	Fisher Diagnostics 8365 Valley Pike Middletown, VA 22645 US Other 510(k) Applications for this Company
Contact	Connie Yang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2017
Decision Date	06/01/2017
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