Name: Predicase
Price: 199 USD

K-number	K121397
Device name	OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
Applicant	SEKISUI Diagnostics, LLC
Product code	KHE
Device class	Class II
Decision date	Dec 28, 2012
Decision	Substantially Equivalent
Regulation	864.6550

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Source

View the full FDA submission: accessdata.fda.gov

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OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT

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