FDA 510(k) Application Details - K011323

Device Classification Name	Enzyme Immunoassay, Cortisol, Salivary   More FDA Info for this Device
510(K) Number	K011323
Device Name	Enzyme Immunoassay, Cortisol, Salivary
Applicant	SALIMETRICS LLC. 101 INNOVATION BLVD. SUITE 302 STATE COLLEGE, PA 16803 US Other 510(k) Applications for this Company
Contact	EVE SCHWARTZ 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	05/01/2001
Decision Date	12/17/2001
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