The following data is part of a premarket notification filed by Weihai Kangzhou Biotechnology Engineering Co., Ltd with the FDA for Kangzhou One Step Hcg Test Strip, Kangzhou One Step Hcg Test Cassette, Kangzhou One Step Hcg Test Midstream.
| Device ID | K183097 |
| 510k Number | K183097 |
| Device Name: | Kangzhou One Step HCG Test Strip, Kangzhou One Step HCG Test Cassette, Kangzhou One Step HCG Test Midstream |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Weihai Kangzhou Biotechnology Engineering Co., Ltd Room401, Building B, Innovation Entrepreneurship Base, High District Weihai City, CN 264200 |
| Contact | Yong Qi |
| Correspondent | Raymond Luo Shanghai SUNGO Management Consulting Company Limited Room 1309, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-07 |
| Decision Date | 2019-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00311917207087 | K183097 | 000 |
| 00808829125672 | K183097 | 000 |
| 06923304600087 | K183097 | 000 |
| 06923304600070 | K183097 | 000 |
| 06923304600049 | K183097 | 000 |
| 06923304600032 | K183097 | 000 |
| 06923304600025 | K183097 | 000 |
| 06923304621129 | K183097 | 000 |
| 06923304621112 | K183097 | 000 |
| 06923304600018 | K183097 | 000 |
| 00808829120615 | K183097 | 000 |
| 06923304621136 | K183097 | 000 |