Name: Predicase
Price: 199 USD

K-number	K013283
Device name	RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
Applicant	Immuno Concepts, Inc.
Product code	MOB
Device class	Class II
Decision date	Nov 14, 2001
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16

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