Submission Details
| 510(k) Number | K150356 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 12, 2015 |
| Decision Date | May 13, 2015 |
| Days to Decision | 90 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
May 2015
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K150356 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 13, 2015, 90 days after receiving the submission on February 12, 2015. This device falls under the Chemistry 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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