K-number	K010428
Device name	ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
Applicant	Beckman Coulter, Inc.
Product code	JJX
Device class	Class I
Decision date	Mar 13, 2001
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349

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