Name: Predicase
Price: 199 USD

K-number	K232587
Device name	MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
Applicant	Shenzhen New Industries Biomedical Engineering Co., Ltd.
Product code	MRG
Device class	Class II
Decision date	Apr 12, 2024
Decision	Substantially Equivalent
Regulation	862.1825

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Source

View the full FDA submission: accessdata.fda.gov

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MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

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