FDA 510(k) Application Details - K952220

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K952220
Device Name	Campylobacter Pylori
Applicant	MERETEK DIAGNOSTICS, INC. 1709 DRYDEN RD. SUITE 1513 HOUSTON, TX 77030 US Other 510(k) Applications for this Company
Contact	CLAUDIA T HITCHCOCK 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	05/11/1995
Decision Date	09/17/1996
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