Name: Predicase
Price: 199 USD

K-number	K073431
Device name	FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
Applicant	Tianjin New Bay Bioresearch Co., Ltd.
Product code	KHE
Device class	Class II
Decision date	Jan 14, 2008
Decision	Substantially Equivalent
Regulation	864.6550

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Source

View the full FDA submission: accessdata.fda.gov

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FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T

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