FDA 510(k) Application Details - K974551

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K974551
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	SEALITE SCIENCES, INC. 3000 NORTHWOODS PKWY. NORCROSS, GA 30071 US Other 510(k) Applications for this Company
Contact	CATHRYN N CAMBRIA 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	12/04/1997
Decision Date	12/22/1997
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