Name: Predicase
Price: 199 USD

K-number	K992188
Device name	NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028
Applicant	Nichols Institute Diagnostics
Product code	JNM
Device class	Class II
Decision date	Dec 6, 1999
Decision	Substantially Equivalent
Regulation	866.5880

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Source

View the full FDA submission: accessdata.fda.gov

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NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028

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