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FDA PRODUCT CODE · CLASS II

NFT — Test, Amphetamine, Over The Counter

DEVICE CLASS
Class II
REGULATION
21 CFR 862.3100
MEDICAL SPECIALTY
Clinical Toxicology
REVIEW PANEL
TX
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
14
510(K)/PMA CLEARANCES
510k: 14
0
RECALL ENTRIES

Recent clearances

K261984Assure Tech., LLC · 510k2026-07-17
K261280Vivachek Biotech (Hangzhou) Co., Ltd. · 510k2026-05-22
K260065Guangzhou Wondfo Biotech Co., Ltd. · 510k2026-04-28
K260355WEBEST Biotech,, LLC · 510k2026-03-09
K252550Guangzhou Wondfo Biotech Co., Ltd. · 510k2025-11-18
K252867Advin Biotech, Inc. · 510k2025-10-09
K252554Vivachek Biotech (Hangzhou) Co., Ltd. · 510k2025-09-12
K252118Hangzhou Clongene Biotech Co., Ltd. · 510k2025-08-27

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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