Name: Predicase
Price: 199 USD

K-number	K904209
Device name	SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	GKZ
Device class	Class II
Decision date	Dec 11, 1990
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE

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