FDA 510(k) Application Details - K170481

Device Classification Name	More FDA Info for this Device
510(K) Number	K170481
Device Name	Strep B Carrot Broth Kit
Applicant	Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 US Other 510(k) Applications for this Company
Contact	Rianna Malherbe Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2017
Decision Date	05/16/2017
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