Name: Predicase
Price: 199 USD

K-number	DEN250032
Device name	LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
Applicant	DiaSorin, Inc.
Product code	SGW
Device class	Class II
Decision date	Dec 23, 2025
Decision	Not Substantially Equivalent
Regulation	866.3176

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)

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