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 Nortriptyline-buprenorphine.
| Device ID | K142609 |
| 510k Number | K142609 |
| Device Name: | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine |
| Classification | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. Wondfo Scientech Park, South China Univ. Of Technology Guangzhou, CN |
| Contact | Ben Chen |
| Correspondent | Joe Shia LSI INTERNATIONAL INC. 504 East Diamond Ave. Suite F Giathersburg, MD 20878 |
| Product Code | LFG |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2014-12-18 |
| Summary: | summary |