The following data is part of a premarket notification filed by Co-innovation Biotech Co., Ltd with the FDA for Rapid Single/multi-drug Test Cup, Rapid Single/multi-drug Test Dipcard.
| Device ID | K153050 |
| 510k Number | K153050 |
| Device Name: | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Co-Innovation Biotech Co., Ltd No. 13, Yanyuan Road, Tianhe District, Guangzhou, CN |
| Contact | Hong Feng |
| Correspondent | Hong Feng Co-Innovation Biotech Co., Ltd No. 13, Yanyuan Road, Tianhe District, Guangzhou, CN 510507 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-20 |
| Decision Date | 2016-04-26 |
| Summary: | summary |