FDA 510(k) Application Details - K091332

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K091332
Device Name	Acid, Folic, Radioimmunoassay
Applicant	Tosoh BioScience, Inc. 3600 GANTZ ROAD GROVE CITY, OH 43123 US Other 510(k) Applications for this Company
Contact	CHARLES P GILL 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	05/06/2009
Decision Date	10/02/2009
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