Device Classification Name |
Kit, Test, Pregnancy, Hcg, Over The Counter
|
510(k) Number |
K171136 |
Device Name |
LIA Pregnancy Test |
Applicant |
LIA Diagnostics |
1015 Chestnut St |
Suite 1401 |
Philadelphia,
PA
19107
|
|
Applicant Contact |
Anna Couturier |
Correspondent |
LIA Diagnostics |
1015 Chestnut St |
Suite 1401 |
Philadelphia,
PA
19107
|
|
Correspondent Contact |
Anna Couturier |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 04/17/2017 |
Decision Date | 11/20/2017 |
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
|
|
|