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 Single/multi-drug Test Dipcard.
| Device ID | K131110 |
| 510k Number | K131110 |
| Device Name: | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | CO-INNOVATION BIOTECH CO., LTD. NO. 13 YANYUAN ROAD. TIANHE DISTRICT Guangzhou, Guangdong, CN 510507 |
| Contact | Hong Feng |
| Correspondent | Hong Feng CO-INNOVATION BIOTECH CO., LTD. NO. 13 YANYUAN ROAD. TIANHE DISTRICT Guangzhou, Guangdong, CN 510507 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DKN |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-19 |
| Decision Date | 2014-01-15 |
| Summary: | summary |