510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NGLClass II

Test, Opiates, Over The Counter

21 CFR 862.3650 / Clinical Toxicology
FDA source (opens on fda.gov)

NGL is the FDA product code for Test, Opiates, Over The Counter, a class II device type, regulated under 21 CFR 862.3650. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NGL
Device name
Test, Opiates, Over The Counter
Regulation
21 CFR 862.3650
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
23
Ingested recalls
0

Clearances, product code NGL

By decision year
23 clearances under product code NGL with a decision year between 2008 and 2025, 2024 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code NGL by decision year
YearClearances
20081
20101
20181
20191
20201
20231
202413
20254

Applicants with the most clearances

Product code NGL
Applicants holding the most 510(k) clearances under product code NGL
ApplicantClearances
Healgen Scientific LLC4
Hangzhou Clongene Biotech Co., Ltd.3
Amedica Biotech, Inc.2
Guangzhou Decheng Biotechnology Co., Ltd.2
Allsource Screening Solutions1
Anhui Deepblue Medical Technological Co., Ltd.1
Assure Tech LLC1
Co-Innovation Biotech Co.,Ltd.1
Eterbio, Inc.1
Guangzhou Wondfo Biotech Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order