Name: Predicase
Price: 199 USD

K-number	K082680
Device name	LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
Applicant	Siemens Healthcare Diagnostics
Product code	JIT
Device class	Class II
Decision date	Oct 10, 2008
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623

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