K-number	K890639
Device name	RESUBMITTED EBV/IGM-CHECK TEST KIT
Applicant	Diagnostic Technology, Inc.
Product code	LJN
Device class	Class I
Decision date	Jun 20, 1989
Decision	Substantially Equivalent
Regulation	866.3235

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View the full FDA submission: accessdata.fda.gov

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RESUBMITTED EBV/IGM-CHECK TEST KIT

Everything you need for a 510(k) submission. Nothing you don't.