Device Classification Name |
anti-jcv antibody detection assay
|
510(k) Number |
K120986 |
Device Name |
STRATIFY JCV DXSELECT |
Applicant |
FOCUS DIAGNOSTICS, INC. |
11331 Valley View Street |
CYPRESS,
CA
90630
|
|
Applicant Contact |
TARA VIVIANI |
Correspondent |
FOCUS DIAGNOSTICS, INC. |
11331 Valley View Street |
CYPRESS,
CA
90630
|
|
Correspondent Contact |
TARA VIVIANI |
Regulation Number | 866.3336
|
Classification Product Code |
|
Date Received | 04/02/2012 |
Decision Date | 08/16/2012 |
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
|
|
|