K-number	K023093
Device name	ACCESS HYPERSENSITIVE HTSH ASSAY
Applicant	Beckman Coulter, Inc.
Product code	JLW
Device class	Class II
Decision date	Nov 25, 2002
Decision	Substantially Equivalent
Regulation	862.1690

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Source

View the full FDA submission: accessdata.fda.gov

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ACCESS HYPERSENSITIVE HTSH ASSAY

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