Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K120413 |
Device Name |
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK |
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 | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/10/2012 |
Decision Date | 07/13/2012 |
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
|
|
|