Name: Predicase
Price: 199 USD

K-number	K182098
Device name	N Latex FLC kappa assay, N Latex FLC lambda assay
Applicant	Siemens Healthcare Diagnostics Products GmbH
Product code	DFH
Device class	Class II
Decision date	Nov 1, 2018
Decision	Substantially Equivalent
Regulation	866.5550

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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N Latex FLC kappa assay, N Latex FLC lambda assay

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