Name: Predicase
Price: 199 USD

K-number	K963263
Device name	TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
Applicant	Coulter Corp.
Product code	GKZ
Device class	Class II
Decision date	Jan 22, 1997
Decision	Substantially Equivalent
Regulation	864.5220

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View the full FDA submission: accessdata.fda.gov

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TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5

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