The following data is part of a premarket notification filed by Nantong Egens Biotech Co., Ltd. with the FDA for Egens Urine Test Cup Thc-mdma, Egens Urine Test Dipcard Thc-mdma, Egens Urine Test Cassette Marijuana.
| Device ID | K152643 |
| 510k Number | K152643 |
| Device Name: | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | NANTONG EGENS BIOTECH CO., LTD. BUILDING 15, 1692 XINGHU AVENUE Nantong, CN 226010 |
| Contact | Yan Cao |
| Correspondent | Joe Shia LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE I Gaithersburg, MD 20877 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2015-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06937579912127 | K152643 | 000 |
| 06937579911373 | K152643 | 000 |