Class Class II

ConcizuTrace™ ELISA (DEN240035)

DEN240035 2025-05-22 Direct
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Description

ConcizuTrace™ ELISA by Randox Laboratories, Ltd. — FDA 510(k) cleared hematology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberDEN240035
Clearance Date2025-05-22
Clearance TypeDirect
Product CodeSES
Regulation Number864.7298

Categories

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