K-number	K151029
Device name	Phadia Prime
Applicant	Phadia AB
Product code	DHB
Device class	Class II
Decision date	Jan 19, 2016
Decision	Substantially Equivalent
Regulation	866.5750

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Source

View the full FDA submission: accessdata.fda.gov

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Phadia Prime

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