Name: Predicase
Price: 199 USD

K-number	K091867
Device name	ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
Applicant	Siemens Healthcare Diagnostics
Product code	CDZ
Device class	Class I
Decision date	Jan 14, 2010
Decision	Substantially Equivalent
Regulation	862.1680

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773

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