FDA 510(k) Application Details - K031501

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K031501
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	AMERICAN HEALTHCARE INC. 304 PARK AVENUE SOUTH SUITE 206 NEW YORK, NY 10010 US Other 510(k) Applications for this Company
Contact	EDWARD LETCO Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2003
Decision Date	10/16/2003
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