Name: Predicase
Price: 199 USD

K-number	K970742
Device name	TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
Applicant	Becton Dickinson Immunocytometry Systems
Product code	GKZ
Device class	Class II
Decision date	Oct 22, 1997
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES

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