Name: Predicase
Price: 199 USD

K-number	K162698
Device name	MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
Applicant	Shenzhen New Industries Biomedical Engineering Co., Ltd.
Product code	JLW
Device class	Class II
Decision date	Jul 14, 2017
Decision	Substantially Equivalent
Regulation	862.1690

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Source

View the full FDA submission: accessdata.fda.gov

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MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

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