K-number	K972697
Device name	AIA-PACK IGE II ASSAY
Applicant	Tosoh Medics, Inc.
Product code	DGC
Device class	Class II
Decision date	Oct 3, 1997
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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AIA-PACK IGE II ASSAY

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