FDA 510(k) Application Details - K140842

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K140842
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	Siemens Healthcare Diagnostics Inc. PO BOX 6101 M/S 514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	FRANCES A DILLON Other 510(k) Applications for this Contact
Regulation Number	862.1695   More FDA Info for this Regulation Number
Classification Product Code	CEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2014
Decision Date	11/26/2014
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