K-number	K884548
Device name	LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
Applicant	Em Diagnostic Systems, Inc.
Product code	CFJ
Device class	Class II
Decision date	Nov 10, 1988
Decision	Substantially Equivalent
Regulation	862.1440

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LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668

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