Name: Predicase
Price: 199 USD

K-number	K061065
Device name	FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
Applicant	Teco Diagnostics
Product code	KHE
Device class	Class II
Decision date	Jul 14, 2006
Decision	Substantially Equivalent
Regulation	864.6550

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Source

View the full FDA submission: accessdata.fda.gov

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FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25

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