K-number	K901090
Device name	ELITECH GAMMA GT TEST KIT
Applicant	Elite Technology, Inc.
Product code	JPZ
Device class	Class I
Decision date	Mar 29, 1990
Decision	Substantially Equivalent
Regulation	862.1360

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View the full FDA submission: accessdata.fda.gov

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ELITECH GAMMA GT TEST KIT

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