K153597 is an FDA 510(k) clearance for the Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card. 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 May 23, 2016, 159 days after receiving the submission on December 16, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K153597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2015 |
| Decision Date | May 23, 2016 |
| Days to Decision | 159 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |