Class Class II

LensHooke X12 PRO Semen Analysis System (K242388)

K242388 2025-05-09 Traditional
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Description

LensHooke X12 PRO Semen Analysis System by Bonraybio Co., Ltd. — FDA 510(k) cleared hematology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242388
Clearance Date2025-05-09
Clearance TypeTraditional
Product CodePOV
Regulation Number864.5220

Categories

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