FDA 510(k) Application Details - K102841

Device Classification Name	Enzyme Immunoassay, Cortisol, Salivary   More FDA Info for this Device
510(K) Number	K102841
Device Name	Enzyme Immunoassay, Cortisol, Salivary
Applicant	PANTEX, DIV. BIO-ANALYSIS, INC. 1701 BERKELEY ST. SANTA MONICA, CA 90404 US Other 510(k) Applications for this Company
Contact	ROMULO GARZA Other 510(k) Applications for this Contact
Regulation Number	862.1205   More FDA Info for this Regulation Number
Classification Product Code	NHG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2010
Decision Date	05/08/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review