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 | K182654 |
| 510k Number | K182654 |
| Device Name: | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card |
| Classification | Test, Methamphetamine, 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 | NGG |
| Subsequent Product Code | NFT |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGI |
| Subsequent Product Code | NGL |
| Subsequent Product Code | NGM |
| Subsequent Product Code | PTG |
| Subsequent Product Code | PTH |
| Subsequent Product Code | QAW |
| Subsequent Product Code | QBF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-25 |
| Decision Date | 2018-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004081609 | K182654 | 000 |