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
|
|
Correspondent Contact |
Thalia Charles |
Regulation Number | 866.3305
|
Classification Product Code |
|
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
|