Name: Predicase
Price: 199 USD

K-number	K100130
Device name	PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
Applicant	Mitsubishi Chemical Medience CO
Product code	MMI
Device class	Class II
Decision date	May 16, 2011
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2

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