Name: Predicase
Price: 199 USD

K-number	K971689
Device name	IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
Applicant	Euro-Diagnostica AB
Product code	MOB
Device class	Class II
Decision date	Oct 29, 1997
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT

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