FDA 510(k) Application Details - K031604

Device Classification Name	Assay, 1,5-Anhydroglucitol (15ag)   More FDA Info for this Device
510(K) Number	K031604
Device Name	Assay, 1,5-Anhydroglucitol (15ag)
Applicant	TOMEN AMERICA INC. 1285 AVENUE OF THE AMERICAS NEW YORK, NY 10019-6028 US Other 510(k) Applications for this Company
Contact	Erika B Ammirati Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	NOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2003
Decision Date	09/22/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review