Cleared Traditional

K202567 - Wondfo T-Dip Multi-Drug Urine Test Panel

K202567 is the FDA 510(k) clearance for Wondfo T-Dip Multi-Drug Urine Test Panel by Guangzhou Wondfo Biotech Co., Ltd.. It is a Class 2 Toxicology device (product code NFT) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K202567 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
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Sep 2020
Decision
21d
Days
Class 2
Risk

K202567 is an FDA 510(k) clearance for the Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test .... Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on September 25, 2020 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K202567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2020
Decision Date September 25, 2020
Days to Decision 21 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 87d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFT Test, Amphetamine, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 Consultant

Lsi International
Joe Shia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NFT Test, Amphetamine, Over The Counter

All 28
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