The following data is part of a premarket notification filed by Hangzhou Sejoy Electronics & Instruments Co., Ltd. with the FDA for Sejoy Hcg One Step Pregnancy Test Strip, Sejoy Hcg One Step Pregnancy Test Cassette, Sejoy Hcg One Step Pregnancy Test Midstream.
| Device ID | K212447 |
| 510k Number | K212447 |
| Device Name: | SEJOY HCG One Step Pregnancy Test Strip, SEJOY HCG One Step Pregnancy Test Cassette, SEJOY HCG One Step Pregnancy Test Midstream |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Hangzhou Sejoy Electronics & Instruments Co., Ltd. Area C, Building 2, No.365 Hangzhou, CN 311100 |
| Contact | Yanyan Zhang |
| Correspondent | Yanyan Zhang Hangzhou Sejoy Electronics & Instruments Co., Ltd. Area C, Building 2, No.365 Hangzhou, CN 311100 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-05 |
| Decision Date | 2022-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06939663982092 | K212447 | 000 |