The following data is part of a premarket notification filed by Healgen Scientific Llc with the FDA for Healgen Multi-drug Urine Test Cup, Healgen Multi-drug Urine Test Dip Card.
| Device ID | K153597 |
| 510k Number | K153597 |
| Device Name: | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| 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 | JXM |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-16 |
| Decision Date | 2016-05-23 |
| Summary: | summary |