Name: Predicase
Price: 199 USD

K-number	K190298
Device name	DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
Applicant	Beckman Coulter Biomedical GmbH
Product code	CDD
Device class	Class II
Decision date	Oct 4, 2019
Decision	Substantially Equivalent
Regulation	862.1810

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

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