Cleared Traditional

ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP

K092048 · Biosite Incorporated · Chemistry
Apr 2010
Decision
286d
Days
Class 2
Risk

About This 510(k) Submission

K092048 is an FDA 510(k) clearance for the ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Biosite Incorporated (San Deigo, US). The FDA issued a Cleared decision on April 19, 2010, 286 days after receiving the submission on July 7, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K092048 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2009
Decision Date April 19, 2010
Days to Decision 286 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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