Name: Predicase
Price: 199 USD

K-number	K990172
Device name	TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
Applicant	Coulter Corp.
Product code	GKZ
Device class	Class II
Decision date	Apr 13, 1999
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 WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA

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