K242830

Substantially Equivalent

LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

Applicant: Bonraybio Co., Ltd.
Product code: POV
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 ↗

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