LensHooke X12 PRO Semen Analysis System— 510(k) K242388

Name: FDA 510(k) clearance K242388
Creator: U.S. Food and Drug Administration
Published: 2025-05-09

Substantially Equivalent

Bonraybio Co., Ltd.

FDA 510(k) clearance K242388 for LensHooke X12 PRO Semen Analysis System, Substantially Equivalent on 2025-05-09. 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: 2024-08-12
Decision date: 2025-05-09
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.