FDA 510(k) Application Details - K042183

Device Classification Name	Drink, Glucose Tolerance   More FDA Info for this Device
510(K) Number	K042183
Device Name	Drink, Glucose Tolerance
Applicant	EVER SCIENTIFIC 7 WETHERILL LANE CHESTER SPRINGS, PA 19425 US Other 510(k) Applications for this Company
Contact	JAY REINHARDT Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	MRV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2004
Decision Date	10/27/2004
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