K-number	K023891
Device name	ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
Applicant	Tosoh Medics, Inc.
Product code	LTK
Device class	Class II
Decision date	Dec 6, 2002
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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ST AIA-PACK CA 125 ENZYME IMMUNOASSAY

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