Name: Predicase
Price: 199 USD

K-number	K081830
Device name	IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1
Applicant	Phadia AB
Product code	DHB
Device class	Class II
Decision date	Mar 16, 2009
Decision	Substantially Equivalent
Regulation	866.5750

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Source

View the full FDA submission: accessdata.fda.gov

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IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1

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