Class Class II

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (K253358)

K253358 2025-12-19 Traditional
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Description

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay by Diazyme Laboratories, Inc. — FDA 510(k) cleared immunology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253358
Clearance Date2025-12-19
Clearance TypeTraditional
Product CodeDFH
Regulation Number866.5550

Categories

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