FDA 510(k) Application Details - K981485

Device Classification Name	Dna-Reagents, Neisseria   More FDA Info for this Device
510(K) Number	K981485
Device Name	Dna-Reagents, Neisseria
Applicant	DIGENE CORP. 9000 VIRGINIA MANOR RD., BELTSVILLE, MD 20705 US Other 510(k) Applications for this Company
Contact	MARK A DEL VECCHIO Other 510(k) Applications for this Contact
Regulation Number	866.3390   More FDA Info for this Regulation Number
Classification Product Code	LSL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/1998
Decision Date	11/29/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review