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 Cocaine Test (strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (strip, Cassette, Cup, Dip Card).
| Device ID | K152269 |
| 510k Number | K152269 |
| Device Name: | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | HEALGEN SCIENTIFIC LLC 5213 MAPLE STREET Bellaire, TX 77401 |
| Contact | Jianqiu Fang |
| Correspondent | Joe Shia LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE I Gaithersburg, MD 20877 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | LAF |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-11 |
| Decision Date | 2015-09-09 |
| Summary: | summary |