The following data is part of a premarket notification filed by Tianjin New Bay Bioresearch Co., Ltd. with the FDA for Rapid One Step Buprenorphine Test Card.
| Device ID | K042988 |
| 510k Number | K042988 |
| Device Name: | RAPID ONE STEP BUPRENORPHINE TEST CARD |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Tianjin New Bay Bioresearch Co., Ltd. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| Contact | Rodrigo Berlie |
| Correspondent | Rodrigo Berlie Tianjin New Bay Bioresearch Co., Ltd. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-29 |
| Decision Date | 2005-05-12 |
| Summary: | summary |