FDA 510(k) Application Details - K971141

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K971141
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	DADE CHEMISTRY SYSTEMS, INC. P.O. BOX 6101, GLASGOW BLDG. 500 MAILBOX 514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	CATHY P CRAFT 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	03/28/1997
Decision Date	04/28/1997
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