Bonraybio Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerMay 30, 2025
K242388LensHooke X12 PRO Semen Analysis SystemMay 9, 2025
K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceOctober 31, 2022
K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerOctober 28, 2020
K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerNovember 16, 2018