The following data is part of a premarket notification filed by Tianjin New Bay Bioresearch Co., Ltd. with the FDA for Forsure One Step Buprenorphine Cup Test Device.
| Device ID | K122064 |
| 510k Number | K122064 |
| Device Name: | FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Tianjin New Bay Bioresearch Co., Ltd. 4455 Murphy Canyon Rd Suite 204 San Diego, CA 92123 |
| Contact | Roger De Bock |
| Correspondent | Roger De Bock Tianjin New Bay Bioresearch Co., Ltd. 4455 Murphy Canyon Rd Suite 204 San Diego, CA 92123 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-13 |
| Decision Date | 2013-05-07 |
| Summary: | summary |