K-number	K842315
Device name	ULTRA LYTE ANALYZER I 100
Applicant	Ultra Quest Diagnostics, Inc.
Product code	CEM
Device class	Class II
Decision date	Aug 2, 1984
Decision	Substantially Equivalent
Regulation	862.1600

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View the full FDA submission: accessdata.fda.gov

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ULTRA LYTE ANALYZER I 100

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