Device Classification Name |
kit, test, pregnancy, hcg, over the counter
|
510(k) Number |
K150022 |
Device Name |
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream |
Applicant |
Guangzhou Wondfo Biotech Co., Ltd. |
Wondfo Scientech Park, South China Univ. of technology |
Guangzhou,
CN
510641
|
|
Applicant Contact |
Ben Chen |
Correspondent |
LSI INTERNATIONAL INC. |
504 EAST DIAMOND AVE. SUITE F |
GAITHERSBURG,
MD
20878
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.1155
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/06/2015 |
Decision Date | 08/07/2015 |
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
|
|
|