Name: Predicase
Price: 199 USD

K-number	K071706
Device name	ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
Applicant	Clinical Data, Inc.
Product code	LBS
Device class	Class I
Decision date	Dec 20, 2007
Decision	Substantially Equivalent
Regulation	862.1475

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)

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