K-number	K964296
Device name	N-ASSAY TIA APO B TEST KIT
Applicant	Crestat Diagnostics, Inc.
Product code	DER
Device class	Class II
Decision date	Aug 1, 1997
Decision	Substantially Equivalent
Regulation	866.5580

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View the full FDA submission: accessdata.fda.gov

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N-ASSAY TIA APO B TEST KIT

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