Cleared Traditional

AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

K152025 · Assure Tech. Co., Ltd. · Chemistry
Oct 2015
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K152025 is an FDA 510(k) clearance for the AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Assure Tech. Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 5, 2015, 75 days after receiving the submission on July 22, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K152025 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2015
Decision Date October 05, 2015
Days to Decision 75 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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