K223162 is an FDA 510(k) clearance for the Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K223162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |