Cleared Traditional

K080347 - UNISCAN -DOA SYSTEM

K080347 is an FDA 510(k) clearance for UNISCAN -DOA SYSTEM, manufactured by Taiwan Unison Biotech, Inc.. The device is a Class 2 Toxicology device with product code DJC cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K080347 · Taiwan Unison Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
244d
Days
Class 2
Risk

K080347 is an FDA 510(k) clearance for the UNISCAN -DOA SYSTEM. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Taiwan Unison Biotech, Inc. (Chunan, Miaoli, TW). The FDA issued a Cleared decision on October 9, 2008 after a review of 244 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Taiwan Unison Biotech, Inc. devices

FDA 510(k) Submission Details - K080347

510(k) Number K080347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 87d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DJC Device Classification - Class 2, Special Controls

Product Code DJC Thin Layer Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DJC Thin Layer Chromatography, Methamphetamine

All 23
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