The following data is part of a premarket notification filed by Healgen Scientific Llc with the FDA for Healgen Amphetamine Test (strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (strip, Cassette, Cup, Dip Card).
| Device ID | K143187 |
| 510k Number | K143187 |
| Device Name: | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Healgen Scientific LLC 5213 Maple St Bellaire, TX 77401 |
| Contact | Jianqiu Fang |
| Correspondent | Joe Shia LSI International Inc. 504 East Diamond Ave. Suite F Gaithersburg, MD 20877 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-05 |
| Decision Date | 2015-01-27 |
| Summary: | summary |