Name: Predicase
Price: 199 USD

K-number	K083487
Device name	EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
Applicant	Siemens Healthcare Diagnostics
Product code	NRP
Device class	Class II
Decision date	Mar 30, 2009
Decision	Substantially Equivalent
Regulation	862.3840

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Source

View the full FDA submission: accessdata.fda.gov

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EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR

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