FDA 510(k) Application Details - K983617

Device Classification Name	Automated Radioimmunoassay Systems, For Clinical Use   More FDA Info for this Device
510(K) Number	K983617
Device Name	Automated Radioimmunoassay Systems, For Clinical Use
Applicant	DIASORIN, INC. 9175 GUIFORD RD. COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	JUDITH J SMITH Other 510(k) Applications for this Contact
Regulation Number	862.2050   More FDA Info for this Regulation Number
Classification Product Code	LCI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/1998
Decision Date	11/16/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review