FDA 510(k) Application Details - K964675

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K964675
Device Name	Campylobacter Pylori
Applicant	PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 VAN NUYS, CA 91401 US Other 510(k) Applications for this Company
Contact	JEANETTE R PORRETTA Other 510(k) Applications for this Contact
Regulation Number	866.3110   More FDA Info for this Regulation Number
Classification Product Code	LYR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/1996
Decision Date	01/27/1997
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