Name: Predicase
Price: 199 USD

K-number	K113349
Device name	HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
Applicant	The Binding Site Group , Ltd.
Product code	DAE
Device class	Class II
Decision date	Jul 11, 2012
Decision	Substantially Equivalent
Regulation	866.5240

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Source

View the full FDA submission: accessdata.fda.gov

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HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO

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