The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Cr3 Keyless Split Sample Cup Secobarbital- Methadone.
| Device ID | K143535 |
| 510k Number | K143535 |
| Device Name: | CR3 Keyless Split Sample Cup Secobarbital- Methadone |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | GUANGZHOU WONDFO BIOTECH CO., LTD. WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY Guangzhou, CN 510641 |
| Contact | Ben Chen |
| Correspondent | Joe Shia LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20878 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-01-13 |
| Summary: | summary |