Device Classification Name |
Dna-Reagents, Neisseria
|
510(k) Number |
K081825 |
Device Name |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY |
Applicant |
BECTON, DICKINSON & CO. |
7 LOVETON CIR. |
SPARKS,
MD
21152 -0999
|
|
Applicant Contact |
KATHRYN B CARR |
Correspondent |
BECTON, DICKINSON & CO. |
7 LOVETON CIR. |
SPARKS,
MD
21152 -0999
|
|
Correspondent Contact |
KATHRYN B CARR |
Regulation Number | 866.3390
|
Classification Product Code |
|
Date Received | 06/27/2008 |
Decision Date | 12/11/2008 |
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
|
Recalls |
CDRH Recalls
|
|
|