FDA 510(k) Application Details - K171338

Device Classification Name	More FDA Info for this Device
510(K) Number	K171338
Device Name	B R A H M S PCT sensitive KRYPTOR
Applicant	B.R.A.H.M.S GmbH Neuendorfstr. 25 Hennigsdorf 16761 DE Other 510(k) Applications for this Company
Contact	Sascha Johannes 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	05/08/2017
Decision Date	05/31/2017
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