Name: Predicase
Price: 199 USD

K-number	K022356
Device name	NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
Applicant	Nichols Institute Diagnostics
Product code	LYR
Device class	Class I
Decision date	Oct 25, 2002
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY

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