FDA 510(k) Application Details - K980088

Device Classification Name	Radioassay, Triiodothyronine Uptake   More FDA Info for this Device
510(K) Number	K980088
Device Name	Radioassay, Triiodothyronine Uptake
Applicant	MONOBIND 729 WEST 16TH ST., C-4 COSTA MESA, CA 92627 US Other 510(k) Applications for this Company
Contact	FREDERICK R JEROME Other 510(k) Applications for this Contact
Regulation Number	862.1715   More FDA Info for this Regulation Number
Classification Product Code	KHQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/1998
Decision Date	02/04/1998
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