Device Classification Name |
visual, pregnancy hcg, prescription use
|
510(k) Number |
K131166 |
Device Name |
SOFIA(R) HCG 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 | 862.1155
|
Classification Product Code |
|
Date Received | 04/24/2013 |
Decision Date | 08/02/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|