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Document Number | K150162 |
Test Name | Express Diagnostics International, Inc., DrugCheck Dip Drug Test |
Manufacturer Name | W.H.P.M., Inc. |
Consumer Information Phone Number | 1(888)466-8433 |
Test Type | Methamphetamine/amphetamine |
Effective Date | 07/02/2019 |
| |
Device Classification Name |
gas chromatography, methamphetamine
|
510(k) Number |
K150162 |
Device Name |
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test |
Applicant |
W.H.P.M., Inc. |
5358 Irwindale Ave. |
Irwindale,
CA
91706
|
|
Applicant Contact |
John Wan |
Correspondent |
W.H.P.M., Inc. |
5358 Irwindale Avenue |
Irwindale,
CA
91706
|
|
Correspondent Contact |
John Wan |
Regulation Number | 862.3610
|
Classification Product Code |
|
Subsequent Product Codes |
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Date Received | 01/26/2015 |
Decision Date | 02/26/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
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