Cleared Traditional

First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test

K151441 · W.H.P.M., Inc. · Chemistry
Jun 2015
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K151441 is an FDA 510(k) clearance for the First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on June 29, 2015, 31 days after receiving the submission on May 29, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K151441 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2015
Decision Date June 29, 2015
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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