FDA 510(k) Application Details - K061509

Device Classification Name	Dna-Reagents, Neisseria   More FDA Info for this Device
510(K) Number	K061509
Device Name	Dna-Reagents, Neisseria
Applicant	GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121-4362 US Other 510(k) Applications for this Company
Contact	BRIAN J SHEA 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	06/01/2006
Decision Date	10/04/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review