First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)— 510(k) K160793

Clearance details

Applicant

W.H.P.M., Inc.

Product code

Code DJR

Device class

Class 2

Regulation

21 CFR 862.3620

Advisory panel

Clinical Toxicology

Date received

2016-03-23

Decision date

2016-08-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irwindale, CA, US

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