FDA 510(k) Application Details - K991650

Device Classification Name	Antisera, Conjugated Fluorescent, Cytomegalovirus   More FDA Info for this Device
510(K) Number	K991650
Device Name	Antisera, Conjugated Fluorescent, Cytomegalovirus
Applicant	BIOTEST DIAGNOSTICS CORP. 66 FORD RD., SUITE 131 DENVILLE, NJ 07834 US Other 510(k) Applications for this Company
Contact	PATRICIA E BONNESS Other 510(k) Applications for this Contact
Regulation Number	866.3175   More FDA Info for this Regulation Number
Classification Product Code	LIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/1999
Decision Date	07/12/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review