Device Classification Name |
dna probe, nucleic acid amplification, chlamydia
|
510(k) Number |
K091724 |
Device Name |
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY |
Applicant |
BECTON DICKINSON & CO. |
7 LOVETON CIR. |
sparks,
MD
21152
|
|
Applicant Contact |
saba modjarrad |
Correspondent |
BECTON DICKINSON & CO. |
7 LOVETON CIR. |
sparks,
MD
21152
|
|
Correspondent Contact |
saba modjarrad |
Regulation Number | 866.3120
|
Classification Product Code |
|
Date Received | 06/11/2009 |
Decision Date | 11/13/2009 |
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
|
|
|