Submission Details
| 510(k) Number | K240686 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 12, 2024 |
| Decision Date | April 12, 2024 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
Apr 2024
Decision
31d
Days
Class 2
Risk
About This 510(k) Submission
K240686 is an FDA 510(k) clearance for the Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on April 12, 2024, 31 days after receiving the submission on March 12, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | NGL — Test, Opiates, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
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