|
|
| Document Number | K161044 |
| Test Name | BTNX Inc. Rapid Response Single/Multi-Drug Test Panel Methamphetamine |
| Manufacturer Name | ASSURE TECH (HANGZHOU) CO., LTD. |
| Consumer Information Phone Number | (800)223-4835 |
| Test Type | Methamphetamines |
| Effective Date | 03/01/2017 |
| |
| Device Classification Name |
thin layer chromatography, methamphetamine
|
|---|
| 510(k) Number |
K161044 |
|---|
| Device Name |
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
|---|
| 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 | 862.3610
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 04/13/2016 |
|---|
| Decision Date | 07/06/2016 |
|---|
| 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
|
|---|
|
|
|
