The following data is part of a premarket notification filed by Shenzhen Bioeasy Biotechnology Co.,ltd. with the FDA for Bioeasy Multi-drug Test Cup.
| Device ID | K193480 |
| 510k Number | K193480 |
| Device Name: | BIOEASY Multi-Drug Test Cup |
| Classification | Test, Opiates, Over The Counter |
| Applicant | Shenzhen Bioeasy Biotechnology Co.,Ltd. No.2-1, Liuxian 1st Road, Xin'an Sub-District Shenzhen, CN 518101 |
| Contact | Wenhau Yan |
| Correspondent | Joe Shia LSI 504E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | NGL |
| Subsequent Product Code | NFT |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| Subsequent Product Code | NGI |
| Subsequent Product Code | NGM |
| Subsequent Product Code | PTG |
| Subsequent Product Code | PTH |
| Subsequent Product Code | QAW |
| Subsequent Product Code | QBF |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972428161820 | K193480 | 000 |