Submission Details
| 510(k) Number | K223162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 07, 2022 |
| Decision Date | March 17, 2023 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Healgen? Accurate Oral Fluid Drug Test, Healgen? Accurate Oral Fluid Drug Test COT
Mar 2023
Decision
161d
Days
Class 2
Risk
About This 510(k) Submission
K223162 is an FDA 510(k) clearance for the Healgen? Accurate Oral Fluid Drug Test, Healgen? Accurate Oral Fluid Drug Test COT, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on March 17, 2023, 161 days after receiving the submission on October 7, 2022. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.
Device Classification
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3870 |
Manufacturer
Similar Devices — LDJ Enzyme Immunoassay, Cannabinoids
All 149
K232732 · Co-Innovation Biotech Co., Ltd.
· Jan 2024
K232604 · Hangzhou Laihe Biotech Co., Ltd.
· Jan 2024
K192515 · Shenzhen Bioeasy Biotechnology Co., Ltd.
· Oct 2019
K153741 · Hangzhou Clongene Biotech Co., Ltd.
· Mar 2016
K152643 · Nantong Egens Biotech Co., Ltd.
· Nov 2015
K151203 · Immunalysis Corporation
· Jun 2015
More from Healgen Scientific, LLC
View all
K252523
· NFW · Feb 2026
K251800
· JMT · Dec 2025
K253567
· NGL · Dec 2025
K251972
· DJG · Aug 2025
K243365
· NGL · Dec 2024