FDA 510(k) Application Details - K172913

Device Classification Name	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr   More FDA Info for this Device
510(K) Number	K172913
Device Name	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Applicant	Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	Pooja Shah Other 510(k) Applications for this Contact
Regulation Number	864.7280   More FDA Info for this Regulation Number
Classification Product Code	NPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2017
Decision Date	01/12/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review