FDA 510(k) Application Details - K981661

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K981661
Device Name	Reagent, Occult Blood
Applicant	AERSCHER DIAGNOSTICS 353 HIGH ST. CHESTERTOWN, MD 21620 US Other 510(k) Applications for this Company
Contact	ROBERT SCHREIBER Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	KHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/1998
Decision Date	09/15/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review