|
Document Number | K122809 |
Test Name | Medical Distribution Group, Inc., Identify Diagnostics Drug Test |
Manufacturer Name | ADVIN BIOTECH |
Consumer Information Phone Number | 1(888)600-0431 |
Test Type | Methylenedioxymethamphetamine (MDMA) |
Effective Date | 06/18/2025 |
| |
Device Classification Name |
Enzyme Immunoassay, Amphetamine
|
510(k) Number |
K122809 |
Device Name |
Advin Multi-Drug Screen Test Cassette, Dip Card and Cup |
Applicant |
ADVIN BIOTECH |
6861 NANCY RIDGE DR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
EDWARD TUNG |
Correspondent |
ADVIN BIOTECH |
10140 Mesa Rim Rd. |
Unit 1 |
San Diego,
CA
92121
|
|
Correspondent Contact |
Yuedan Huang |
Regulation Number | 862.3100 |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/13/2012 |
Decision Date | 06/17/2013 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|
|