The following data is part of a premarket notification filed by Healgen Scientific Llc with the FDA for Healgen Oxazepam Test (strip, Cassette, Cup, Dip Card), Healgen Morphine Test (strip, Cassette, Cup, Dip Card).
| Device ID | K142280 |
| 510k Number | K142280 |
| Device Name: | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | HEALGEN SCIENTIFIC LLC 5213 MAPLE STREET Bellaire, TX 77401 |
| Contact | Jianqiu Fang |
| Correspondent | Joe Xia LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE I 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 | 2014-08-15 |
| Decision Date | 2014-10-16 |
| Summary: | summary |