K151348 is an FDA 510(k) clearance for the Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card). This device is classified as a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II - Special Controls, product code LFG).
Submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on August 18, 2015, 90 days after receiving the submission on May 20, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3910. Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine..
| 510(k) Number | K151348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2015 |
| Decision Date | August 18, 2015 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LFG — Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3910 |
| Definition | Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine. |