FDA 510(k) Application Details - K980888

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K980888
Device Name	Assay, Glycosylated Hemoglobin
Applicant	EXOCELL, INC. 3508 MARKET ST., SUITE 420 PHILADELPHIA, PA 19104 US Other 510(k) Applications for this Company
Contact	MARGO P COHEN Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/1998
Decision Date	08/13/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review