Name: Predicase
Price: 199 USD

K-number	K171742
Device name	N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2
Applicant	Siemens Healthcare Diagnostics Products GmbH
Product code	DFH
Device class	Class II
Decision date	Nov 17, 2017
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, N FLC Standard SL, N FLC Control SL1 & SL2

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