Device Classification Name |
kit, test, pregnancy, hcg, over the counter
|
510(k) Number |
K234152 |
Device Name |
ACESO Early Pregnancy Test |
Applicant |
Aceso Laboratories, Inc. |
14020 Central Avenue, Suite 520 |
Chino,
CA
91710
|
|
Applicant Contact |
Yinfei Wu |
Correspondent |
LSI International Inc |
504E Diamond Ave., Suite H |
Gaithersburg,
MD
20877
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 12/29/2023 |
Decision Date | 04/05/2024 |
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
|
|
|