The following data is part of a premarket notification filed by Healgen Scientific Llc with the FDA for 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).
| Device ID | K151348 |
| 510k Number | K151348 |
| Device Name: | 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) |
| Classification | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Applicant | HEALGEN SCIENTIFIC LLC 5213 MAPLE ST Bellaire, TX 77401 |
| Contact | Jianqiu Fang |
| Correspondent | Joe Xia LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE I Gaithersburg, MD 20877 |
| Product Code | LFG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXN |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-20 |
| Decision Date | 2015-08-18 |
| Summary: | summary |