FDA 510(k) Application Details - K992365

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K992365
Device Name	Acid, Folic, Radioimmunoassay
Applicant	TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	JUDITH E LOEBEL 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	07/15/1999
Decision Date	08/10/1999
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