Device Classification Name |
test, amphetamine, over the counter
|
510(k) Number |
K233062 |
Device Name |
BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx |
Applicant |
VivaChek Biotech (Hangzhou) Co., Ltd |
Level 2, Block 2, 146 East Chaofeng Rd., |
Yuhang Economy Development Zone |
Hangzhou,
CN
311100
|
|
Applicant Contact |
Jessica 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 | 09/26/2023 |
Decision Date | 11/02/2023 |
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
|
|
|