FDA 510(k) Application Details - DEN150058

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150058
Device Name	Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
Applicant	Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Elizabeth Platt Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2015
Decision Date	03/28/2016
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review