Device Classification Name |
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
|
510(k) Number |
K100148 |
Device Name |
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 |
Applicant |
FOCUS DIAGNOSTICS, INC. |
11331 VALLEY VIEW ST. |
CYPRESS,
CA
90630
|
|
Applicant Contact |
TARA VIVIANI |
Correspondent |
FOCUS DIAGNOSTICS, INC. |
11331 VALLEY VIEW ST. |
CYPRESS,
CA
90630
|
|
Correspondent Contact |
TARA VIVIANI |
Regulation Number | 866.3332
|
Classification Product Code |
|
Date Received | 01/19/2010 |
Decision Date | 05/24/2010 |
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
|
|
|