Bonraybio Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: LensHooke X3 PRO Semen Quality Analyzer, LensHooke X12 PRO Semen Analysis System, LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bonraybio Co., Ltd. Hematology ✕
4 devices
Cleared
May 30, 2025
LensHooke X3 PRO Semen Quality Analyzer
Hematology
253d
Cleared
May 09, 2025
LensHooke X12 PRO Semen Analysis System
Hematology
270d
Cleared
Oct 28, 2020
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality...
Hematology
92d
Cleared
Nov 16, 2018
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
Hematology
282d