Device Classification Name |
antigens, cf (including cf control), influenza virus a, b, c
|
510(k) Number |
K132352 |
Device Name |
SAS FLUALERT A & B, SAS INFLUENZA A TEST |
Applicant |
SA SCIENTIFIC LTD. |
4919 GOLDEN QUAIL |
SAN ANTONIO,
TX
78240
|
|
Applicant Contact |
Nelson Torres |
Correspondent |
SA SCIENTIFIC LTD. |
4919 GOLDEN QUAIL |
SAN ANTONIO,
TX
78240
|
|
Correspondent Contact |
Nelson Torres |
Regulation Number | 866.3330
|
Classification Product Code |
|
Date Received | 07/29/2013 |
Decision Date | 08/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|