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 And Rapid Single/multi-drug Test Dipcard.
| Device ID | K142800 |
| 510k Number | K142800 |
| Device Name: | Rapid Single/Multi-drug Test Cup And Rapid Single/Multi-drug Test Dipcard |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Co-Innovation Biotech Co., Ltd. No. 13, Yanyuan Road, Tianhe District Guangzhou, CN 510507 |
| Contact | Hong Feng |
| Correspondent | Hong Feng Co-Innovation Biotech Co., Ltd. No. 13, Yanyuan Road, Tianhe District Guangzhou, CN 510507 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-29 |
| Decision Date | 2014-12-11 |
| Summary: | summary |