Name: Predicase
Price: 199 USD

K-number	K090901
Device name	ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
Applicant	Osmetech Molecular Diagnostics
Product code	NUA
Device class	Class II
Decision date	Jul 6, 2009
Decision	Substantially Equivalent
Regulation	866.5900

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Source

View the full FDA submission: accessdata.fda.gov

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ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8

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