Name: Predicase
Price: 199 USD

K-number	K170028
Device name	FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
Applicant	Dako Denmark A/S
Product code	MYA
Device class	Class II
Decision date	Dec 21, 2017
Decision	Substantially Equivalent
Regulation	864.1860

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Source

View the full FDA submission: accessdata.fda.gov

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FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)

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