Name: Predicase
Price: 199 USD

K-number	DEN160025
Device name	ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
Applicant	Id-Fish Technology, Inc.
Product code	PYN
Device class	Class II
Decision date	Aug 18, 2017
Decision	Not Substantially Equivalent
Regulation	866.3367

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Source

View the full FDA submission: accessdata.fda.gov

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ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

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