|
Document Number | K160793 |
Test Name | W. H. P. M. First Sign Drug of Abuse Nortriptyline Cup Test |
Manufacturer Name | W.H.P.M., INC. |
Consumer Information Phone Number | (888)436-6787 |
Test Type | Tricyclic antidepressants |
Effective Date | 08/25/2016 |
| |
Device Classification Name |
Enzyme Immunoassay, Methadone
|
510(k) Number |
K160793 |
Device Name |
First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) |
Applicant |
W.H.P.M., INC. |
5358 IRWINDALE AVE. |
IRWINDALE,
CA
91706
|
|
Applicant Contact |
John Wan |
Correspondent |
LSI Consulting |
504 East Diamond Ave., Suite I |
Gaithersburg,
MD
20877
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.3620
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/23/2016 |
Decision Date | 08/17/2016 |
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
|
|
|
|