FDA 510(k) Application Details - K010893

Device Classification Name	Dna-Reagents, Neisseria   More FDA Info for this Device
510(K) Number	K010893
Device Name	Dna-Reagents, Neisseria
Applicant	DIGENE CORP. 1201 CLOPPER RD. GAITHERSBURG, MD 20878 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	03/26/2001
Decision Date	09/24/2001
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