FDA 510(k) Application Details - K060578

Device Classification Name	Radioimmunoassay, Calcitonin   More FDA Info for this Device
510(K) Number	K060578
Device Name	Radioimmunoassay, Calcitonin
Applicant	SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY SANTEE, CA 92071 US Other 510(k) Applications for this Company
Contact	MICHAEL NORDSTROM Other 510(k) Applications for this Contact
Regulation Number	862.1140   More FDA Info for this Regulation Number
Classification Product Code	JKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2006
Decision Date	08/30/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review