510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NFTClass II

Test, Amphetamine, Over The Counter

21 CFR 862.3100 / Clinical Toxicology
FDA source (opens on fda.gov)

NFT is the FDA product code for Test, Amphetamine, Over The Counter, a class II device type, regulated under 21 CFR 862.3100. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NFT
Device name
Test, Amphetamine, Over The Counter
Regulation
21 CFR 862.3100
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
32
Ingested recalls
0

Clearances, product code NFT

By decision year
32 clearances under product code NFT with a decision year between 2017 and 2026, 2025 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code NFT by decision year
YearClearances
20171
20186
20191
20202
20211
20223
20231
20244
20258
20265

Applicants with the most clearances

Product code NFT
Applicants holding the most 510(k) clearances under product code NFT
ApplicantClearances
Guangzhou Wondfo Biotech Co., Ltd.4
Hangzhou AllTest Biotech Co.,Ltd4
Vivachek Biotech (Hangzhou) Co., Ltd4
Assure Tech. (Hangzhou) Co., Ltd.3
Assure Tech LLC3
Safecare Biotech(hangzhou)co.,Ltd3
Aicheck Biotech, Inc.2
Healstone Biotech Inc.2
Advin Biotech, Inc.1
Bioteke Corporation (Wuxi) Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order