Cleared Traditional

UNISCAN -DOA SYSTEM

K080347 · Taiwan Unison Biotech, Inc. · Toxicology
Oct 2008
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K080347 is an FDA 510(k) clearance for the UNISCAN -DOA SYSTEM, a Thin Layer Chromatography, Methamphetamine (Class II — Special Controls, product code DJC), submitted by Taiwan Unison Biotech, Inc. (Chunan, Miaoli, TW). The FDA issued a Cleared decision on October 9, 2008, 244 days after receiving the submission on February 8, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K080347 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2008
Decision Date October 09, 2008
Days to Decision 244 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJC — Thin Layer Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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