K-number	K960434
Device name	INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
Applicant	Incstar Corp.
Product code	LFZ
Device class	Class II
Decision date	Oct 17, 1996
Decision	Substantially Equivalent
Regulation	866.3175

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INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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