|
Document Number | K182701 |
Test Name | Rapid Self Test Inc., RST Home Multi-Drug Test Kit Cup (Urine) |
Manufacturer Name | Guangzhou Wondfo Biotech Co., Ltd. |
Consumer Information Phone Number | 866-805-6440 |
Test Type | Amphetamines |
Effective Date | 12/20/2019 |
| |
Device Classification Name |
test, amphetamine, over the counter
|
510(k) Number |
K182701 |
Device Name |
Wondfo T-Cup Multi-Drug Urine Test Cup |
Applicant |
Guangzhou Wondfo Biotech Co., Ltd. |
No.8 Lizhishan Road, Science City |
Guangzhou,
CN
510641
|
|
Applicant Contact |
Bin Chen |
Correspondent |
LSI International |
504 E Diamond Ave., Suite I |
Gaithersburg,
MD
20877
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.3100
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/27/2018 |
Decision Date | 12/03/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|
|