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

Name: FDA 510(k) clearance K242830
Creator: U.S. Food and Drug Administration
Published: 2025-05-30

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.. Device class: 2.

Clearance details

Applicant: Bonraybio Co., Ltd.
Product code: Code POV
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2024-09-19
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.