K-number	K854944
Device name	TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT
Applicant	Abbott Laboratories
Product code	DAH
Device class	Class II
Decision date	Aug 27, 1986
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT

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