LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer— 510(k) K242830

Substantially Equivalent

Bonraybio Co., Ltd.

FDA 510(k) clearance K242830 for LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer, Substantially Equivalent on 2025-05-30. Applicant: Bonraybio Co., Ltd..

Clearance details

Applicant: Bonraybio Co., Ltd.
Product code: Code POV
Advisory panel: Hematology
Date received: 2024-09-19
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

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