K-number	K031606
Device name	ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
Applicant	Beckman Coulter, Inc.
Product code	LFX
Device class	Class II
Decision date	Jun 20, 2003
Decision	Substantially Equivalent
Regulation	866.3510

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View the full FDA submission: accessdata.fda.gov

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ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY

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