Submission Details
| 510(k) Number | K151642 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 18, 2015 |
| Decision Date | August 13, 2015 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Aug 2015
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K151642 is an FDA 510(k) clearance for the Heagen 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 13, 2015, 56 days after receiving the submission on June 18, 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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