FDA 510(k) Application Details - K970016

Device Classification Name	Radioimmunoassay, Total Triiodothyronine   More FDA Info for this Device
510(K) Number	K970016
Device Name	Radioimmunoassay, Total Triiodothyronine
Applicant	JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. ROCHESTER, NY 14650-0882 US Other 510(k) Applications for this Company
Contact	ANN M QUINN Other 510(k) Applications for this Contact
Regulation Number	862.1710   More FDA Info for this Regulation Number
Classification Product Code	CDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/1997
Decision Date	01/30/1997
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