K-number	K013606
Device name	ACS 180 HOMOCYSTEINE ASSAY
Applicant	Bayer Diagnostics Corp.
Product code	LPS
Device class	Class II
Decision date	Dec 21, 2001
Decision	Substantially Equivalent
Regulation	862.1377

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View the full FDA submission: accessdata.fda.gov

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ACS 180 HOMOCYSTEINE ASSAY

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