K-number	K071961
Device name	MESACUP MODELS BP180 AND BP230 ELISA KITS
Applicant	Mbl International Corporation
Product code	OEG
Device class	Class II
Decision date	Aug 25, 2008
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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MESACUP MODELS BP180 AND BP230 ELISA KITS

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