Device Classification Name |
Dna-Reagents, Neisseria
|
510(k) Number |
K061509 |
Device Name |
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 |
Applicant |
GEN-PROBE, INC. |
10210 GENETIC CENTER DR. |
SAN DIEGO,
CA
92121 -4362
|
|
Applicant Contact |
BRIAN J SHEA |
Correspondent |
GEN-PROBE, INC. |
10210 GENETIC CENTER DR. |
SAN DIEGO,
CA
92121 -4362
|
|
Correspondent Contact |
BRIAN J SHEA |
Regulation Number | 866.3390
|
Classification Product Code |
|
Date Received | 06/01/2006 |
Decision Date | 10/04/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|