LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer— 510(k) K180343

Substantially Equivalent

Bonraybio Co., Ltd.

FDA 510(k) clearance K180343 for LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer, Substantially Equivalent on 2018-11-16. Applicant: Bonraybio Co., Ltd..

Clearance details

Applicant: Bonraybio Co., Ltd.
Product code: Code POV
Advisory panel: Hematology
Date received: 2018-02-07
Decision date: 2018-11-16
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.