|
Document Number | K181768 |
Test Name | 12 Panel Now (DBA) Hospital Connect Inc, 12panel now Panel Dip Tests |
Manufacturer Name | Assure Tech (Hangzhou) Co., Ltd. |
Consumer Information Phone Number | 1(888)936-6627 |
Test Type | Tricyclic antidepressants |
Effective Date | 05/03/2019 |
| |
Device Classification Name |
Test, Amphetamine, Over The Counter
|
510(k) Number |
K181768 |
Device Name |
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests |
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 I |
Gaithersburg,
MD
20877
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.3100
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/03/2018 |
Decision Date | 08/20/2018 |
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
|
|
|
|