The following data is part of a premarket notification filed by Safecare Biotech(hangzhou)co.,ltd. with the FDA for Safecare Multi-drug Urine Test Cup, Safecare Multi-drug Urine Test Dip-card.
| Device ID | K181968 |
| 510k Number | K181968 |
| Device Name: | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card |
| Classification | Test, Amphetamine, Over The Counter |
| Applicant | Safecare Biotech(Hangzhou)Co.,Ltd. Building 2/203 No.18 Haishu Rd. Cangqian Sub-district, Yuhang District Hangzhou, CN 311121 |
| Contact | Alex Qiu |
| Correspondent | Joe Shia LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | NFT |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| Subsequent Product Code | NGL |
| Subsequent Product Code | PTG |
| Subsequent Product Code | PTH |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-24 |
| Decision Date | 2018-08-20 |
| Summary: | summary |