K-number	K893737
Device name	DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
Applicant	Quidel Corp.
Product code	KTN
Device class	Class II
Decision date	Jun 16, 1989
Decision	Substantially Equivalent
Regulation	866.5640

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View the full FDA submission: accessdata.fda.gov

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DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST

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