Device Classification Name |
Test, Amphetamine, Over The Counter
|
510(k) Number |
K170049 |
Device Name |
AssureTech Panel Dip Test, AssureTech Quick Cup Test |
Applicant |
ASSURE TECH (HANGZHOU) CO., LTD. |
NO.10, XIYUANSAN RD. |
WESTLAKE ECONOMIC ZONE |
HANGZHOU,
CN
310030
|
|
Applicant Contact |
SHISHENG LING |
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 | 01/05/2017 |
Decision Date | 05/02/2017 |
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
|
|
|