The following data is part of a premarket notification filed by Nantong Egens Biotech Co., Ltd. with the FDA for Egens Urine Test Cup Morphine - Methamphetamine, Egens Urine Dipcard Morphine - Methamphetamine.
| Device ID | K151557 |
| 510k Number | K151557 |
| Device Name: | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine |
| Classification | Thin Layer Chromatography, Morphine |
| Applicant | NANTONG EGENS BIOTECH CO., LTD. BUILDING 15, 1692 XINGHU AVENUE Nantong, CN 226010 |
| Contact | Ben Chen |
| Correspondent | Joe Shia LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE I Gaithersburg, MD 20878 |
| Product Code | DNK |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-10 |
| Decision Date | 2015-07-16 |
| Summary: | summary |