The following data is part of a premarket notification filed by Safecare Biotech (hangzhou) Co., Ltd. with the FDA for Hcg Urine Test Strip, Hcg Urine Test Cassette, Hcg Urine Test Midstream.
| Device ID | K200133 |
| 510k Number | K200133 |
| Device Name: | HCG Urine Test Strip, HCG Urine Test Cassette, HCG Urine Test Midstream |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Safecare Biotech (Hangzhou) Co., Ltd. 18 Haishu Road, Yuhang District Hangzhou, CN |
| Contact | Selina Zhang |
| Correspondent | Selina Zhang Safecare Biotech (Hangzhou) Co., Ltd. 18 Haishu Road, Yuhang District Hangzhou, CN |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974246460833 | K200133 | 000 |