LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer— 510(k) K202089

Substantially Equivalent

Bonraybio Co., Ltd.

FDA 510(k) clearance K202089 for LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer, Substantially Equivalent on 2020-10-28. Applicant: Bonraybio Co., Ltd..

Clearance details

Applicant: Bonraybio Co., Ltd.
Product code: Code POV
Advisory panel: Hematology
Date received: 2020-07-28
Decision date: 2020-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Taichung, TW

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