Name: Predicase
Price: 199 USD

K-number	K011164
Device name	MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
Applicant	Syva Co., Dade Behring, Inc.
Product code	KXS
Device class	Class II
Decision date	May 10, 2001
Decision	Substantially Equivalent
Regulation	862.3630

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229

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