Device Classification Name |
kit, test, pregnancy, hcg, over the counter
|
510(k) Number |
K233174 |
Device Name |
FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream |
Applicant |
Assure Tech (Hangzhou) Co., Ltd. |
2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road |
Gongshu District |
Hangzhou,
CN
310011
|
|
Applicant Contact |
Shisheng Ling |
Correspondent |
LSI International |
504 E Diamond Ave., Suite H |
Gaithersburg,
MD
20877
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 09/28/2023 |
Decision Date | 02/05/2024 |
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
|
|
|