FDA 510(k) Application Details - K183298

Device Classification Name	Susceptibility Test Discs, Antimicrobial   More FDA Info for this Device
510(K) Number	K183298
Device Name	Susceptibility Test Discs, Antimicrobial
Applicant	Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 US Other 510(k) Applications for this Company
Contact	Anna Klavins Other 510(k) Applications for this Contact
Regulation Number	866.1620   More FDA Info for this Regulation Number
Classification Product Code	JTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2018
Decision Date	01/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review