K163704 is an FDA 510(k) clearance for the Healgen Multi-Drug Urine Test Cup. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on August 2, 2017, 216 days after receiving the submission on December 29, 2016.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K163704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2016 |
| Decision Date | August 02, 2017 |
| Days to Decision | 216 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |