Device Classification Name |
respiratory virus panel nucleic acid assay system
|
510(k) Number |
K142365 |
Device Name |
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack |
Applicant |
FOCUS DIAGNOSTICS |
11331 Valley View Street |
CYPRESS,
CA
90630
|
|
Applicant Contact |
Sharon Young |
Correspondent |
FOCUS DIAGNOSTICS |
11331 Valley View Street |
CYPRESS,
CA
90630
|
|
Correspondent Contact |
Sharon Young |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/25/2014 |
Decision Date | 12/05/2014 |
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
|