Submission Details
| 510(k) Number | K163704 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 2016 |
| Decision Date | August 02, 2017 |
| Days to Decision | 216 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | — |
Cleared
Special
Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
Aug 2017
Decision
216d
Days
Class 2
Risk
About This 510(k) Submission
K163704 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 August 2, 2017, 216 days after receiving the submission on December 29, 2016. 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
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