FDA 510(k) Applications Submitted by Bonraybio Co., LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K202089 07/28/2020 LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer Bonraybio Co., Ltd.
K180343 02/07/2018 LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer Bonraybio Co., Ltd.
K221810 06/22/2022 LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device Bonraybio Co., LTD.


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