Name: Predicase
Price: 199 USD

K-number	K021516
Device name	DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
Applicant	Axis-Shield Diagnostics, Ltd.
Product code	NHX
Device class	Class II
Decision date	Jul 23, 2002
Decision	Substantially Equivalent
Regulation	866.5775

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Source

View the full FDA submission: accessdata.fda.gov

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DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

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