K-number	K842526
Device name	AMIZYME-LEISHMANIA SPP. TEST KIT
Applicant	Amico Lab, Inc.
Product code	LOO
Device class	Class I
Decision date	Aug 28, 1984
Decision	Substantially Equivalent
Regulation	866.3870

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View the full FDA submission: accessdata.fda.gov

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AMIZYME-LEISHMANIA SPP. TEST KIT

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