FDA 510(k) Application Details - K171511

Device Classification Name	More FDA Info for this Device
510(K) Number	K171511
Device Name	RIDA GENE Norovirus GI/GII
Applicant	R-Biopharm AG An der neuen Bergstrabe 17 Darmstadt 64297 DE Other 510(k) Applications for this Company
Contact	Andreas Simons Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2017
Decision Date	08/21/2017
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