FDA 510(k) Application Details - K963498

Device Classification Name	Radioimmunoassay (Two-Site Solid Phase), Ferritin   More FDA Info for this Device
510(K) Number	K963498
Device Name	Radioimmunoassay (Two-Site Solid Phase), Ferritin
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	866.5340   More FDA Info for this Regulation Number
Classification Product Code	JMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/1996
Decision Date	01/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review