Name: Predicase
Price: 199 USD

K-number	K220001
Device name	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Applicant	Diazyme Laboratories, Inc.
Product code	DFH
Device class	Class II
Decision date	Aug 4, 2022
Decision	Substantially Equivalent
Regulation	866.5550

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Source

View the full FDA submission: accessdata.fda.gov

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Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

Everything you need for a 510(k) submission. Nothing you don't.