FDA 510(k) Application Details - K150528

Device Classification Name	Enzyme Immunoassay, Cortisol, Salivary   More FDA Info for this Device
510(K) Number	K150528
Device Name	Enzyme Immunoassay, Cortisol, Salivary
Applicant	IBL INTERNATIONAL GMBH FLUGHAFENSTRASSE 52 A HAMBURG D-22335 DE Other 510(k) Applications for this Company
Contact	NICOLA KAISER 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	03/02/2015
Decision Date	11/25/2015
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