FDA 510(k) Application Details - K981931

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K981931
Device Name	Acid, Folic, Radioimmunoassay
Applicant	ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH 4300 HACIENDA DR. PLEASANTON, CA US Other 510(k) Applications for this Company
Contact	Patricia M Klimley Other 510(k) Applications for this Contact
Regulation Number	862.1295   More FDA Info for this Regulation Number
Classification Product Code	CGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/1998
Decision Date	08/25/1998
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