FDA 510(k) Application Details - K190553

Device Classification Name	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar   More FDA Info for this Device
510(K) Number	K190553
Device Name	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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	866.1700   More FDA Info for this Regulation Number
Classification Product Code	JSO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2019
Decision Date	04/29/2019
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