← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

NGL — Test, Opiates, Over The Counter

DEVICE CLASS
Class II
REGULATION
21 CFR 862.3650
MEDICAL SPECIALTY
Clinical Toxicology
REVIEW PANEL
TX
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES

Recent clearances

K253567Healgen Scientific,, LLC · 510k2025-12-23
K250803Anhui Deepblue Medical Technological Co., Ltd. · 510k2025-04-15
K250067Guangzhou Decheng Biotechnology Co., Ltd. · 510k2025-02-20
K242428Guangzhou Decheng Biotechnology Co., Ltd. · 510k2025-02-06
K243365Healgen Scientific,, LLC · 510k2024-12-17
K243064Eterbio, Inc. · 510k2024-11-20
K242802Hangzhou Clongene Biotech Co., Ltd. · 510k2024-11-08
K241869Vivachek Biotech (Hangzhou) Co., Ltd. · 510k2024-10-04

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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