Submission Details
| 510(k) Number | K153597 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
May 2016
Decision
159d
Days
Class 2
Risk
About This 510(k) Submission
K153597 is an FDA 510(k) clearance for the Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card, 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 review panel. Regulated under 21 CFR 862.3170.
Device Classification
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3170 |
Manufacturer
Similar Devices — JXM Enzyme Immunoassay, Benzodiazepine
All 89
K243498 · Microgenics Corporation
· Dec 2024
K221765 · Roche Diagnostics
· Dec 2022
K190968 · Microgenics Corporation
· Dec 2019
K173963 · Microgenics Corporation
· Feb 2018
K163590 · Psychemedics Corporation
· Sep 2017
K163704 · Healgen Scientific, LLC
· Aug 2017
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