Device Classification Name |
antigens, all groups, streptococcus spp.
|
510(k) Number |
K141775 |
Device Name |
SOFIA (R) STREP A+ FIA |
Applicant |
QUIDEL CORPORATION |
12544 HIGH BLUFF (ADMINISTRATIVE OFFICE LOCATION) |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
JOHN D TAMERIUS |
Correspondent |
QUIDEL CORPORATION |
12544 HIGH BLUFF (ADMINISTRATIVE OFFICE LOCATION) |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
JOHN D TAMERIUS |
Regulation Number | 866.3740
|
Classification Product Code |
|
Date Received | 07/01/2014 |
Decision Date | 12/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Dual Track
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|