Device Classification Name |
Devices Detecting Influenza A, B, And C Virus Antigens
|
510(k) Number |
K112177 |
Device Name |
SOFIA ANALYZER AND INFLUENZA A+B FIA |
Applicant |
QUIDEL CORP. |
10165 MCKELLAR CT. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
JOHN D TAMERIUS |
Correspondent |
QUIDEL CORP. |
10165 MCKELLAR CT. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
JOHN D TAMERIUS |
Regulation Number | 866.3328
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/28/2011 |
Decision Date | 10/24/2011 |
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
|
|
|