Name: Predicase
Price: 199 USD

K-number	K061360
Device name	NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
Applicant	Lab Vision Corp.
Product code	MYA
Device class	Class II
Decision date	Jun 27, 2006
Decision	Substantially Equivalent
Regulation	864.1860

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Source

View the full FDA submission: accessdata.fda.gov

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NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)

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