The following data is part of a premarket notification filed by Shanghai Venture Bio-tech Co., Ltd. with the FDA for Bio-venture Rapid Multi-drug Test Easy Cup For Otc Use, Bio-venture Rapid Multi-drug Test Split Key Cup For Otc Use, Bio-venture Rapid Multi-drug Test Easy Cup For Rx Use, Bio-venture Rapid Multi-drug Test Split Key Cup For Rx Use.
| Device ID | K180879 |
| 510k Number | K180879 |
| Device Name: | BIO-VENTURE Rapid Multi-Drug Test Easy Cup For OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup For OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup For Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup For Rx Use |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | SHANGHAI VENTURE BIO-TECH CO., LTD. Room 313, Building 2, No. 2715 Longwu Road, Xuhui District Shanghai, CN 200231 |
| Contact | Longli Long |
| Correspondent | Ethan Liu Shanghai Thinkwell Consulting Co., Ltd. Floor 6, No.211, Xin Ling Road, Minhang District Shanghai, CN 201100 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | NFT |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| Subsequent Product Code | NGI |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-03 |
| Decision Date | 2018-12-14 |
| Summary: | summary |