The following data is part of a premarket notification filed by Co-innovation Biotech Co.,ltd. with the FDA for One Step Single/multi-drug Test Cup, One Step Single/multi-drug Test Dipcard.
| Device ID | K140748 |
| 510k Number | K140748 |
| Device Name: | ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-25 |
| Decision Date | 2014-08-20 |
| Summary: | summary |