K-number	K031270
Device name	ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant	Beckman Coulter, Inc.
Product code	DHX
Device class	Class II
Decision date	May 6, 2003
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

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