The following data is part of a premarket notification filed by Bonraybio Co., Ltd. with the FDA for Lenshooke X1 Pro Semen Quality Analyzer, Lenshooke X1 Semen Quality Analyzer.
| Device ID | K180343 |
| 510k Number | K180343 |
| Device Name: | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer |
| Classification | Semen Analysis Device |
| Applicant | Bonraybio Co., Ltd. 4F., No.118, Gongye 9th Rd. Dali Dist. Taichung, TW 41280 |
| Contact | Clare Huang |
| Correspondent | Feng-yu Lee Dynamic Biotech Inc. Dba IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-07 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719874740702 | K180343 | 000 |