Name: Predicase
Price: 199 USD

K-number	K150879
Device name	LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
Applicant	DiaSorin, Inc.
Product code	CEW
Device class	Class II
Decision date	Jun 22, 2015
Decision	Substantially Equivalent
Regulation	862.1545

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Source

View the full FDA submission: accessdata.fda.gov

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LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers

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