BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS


Device Classification Name

herpes simplex virus nucleic acid amplification assay

510(k) Number K103798
Device Name BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
Applicant
BECTON DICKINSON & CO.
7 loveton cir.
baltimore, 
MD 
21152

Applicant Contact thalia charles
Correspondent
BECTON DICKINSON & CO.
7 loveton cir.
baltimore, 
MD 
21152

Correspodent Contact thalia charles
Regulation Number 866.3305
Classification Product Code
OQO  
Date Received 12/27/2010
Decision Date 03/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No