Name: Predicase
Price: 199 USD

K-number	K060543
Device name	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
Applicant	Clinical Micro Sensors, Inc.
Product code	NUA
Device class	Class II
Decision date	Mar 28, 2006
Decision	Substantially Equivalent
Regulation	866.5900

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Source

View the full FDA submission: accessdata.fda.gov

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ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800

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