FDA 510(k) Application Details - K180041

Device Classification Name	More FDA Info for this Device
510(K) Number	K180041
Device Name	BioCode Gastrointestinal Pathogen Panel (GPP)
Applicant	Applied Biocode, Inc. 10020 Pioneer Blvd. Suite 102 Santa Fe Springs, CA 90670 US Other 510(k) Applications for this Company
Contact	Robert Di Tullio Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2018
Decision Date	09/28/2018
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