Name: Predicase
Price: 199 USD

K-number	K040073
Device name	SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
Applicant	Sysmex America, Inc.
Product code	GKZ
Device class	Class II
Decision date	Mar 18, 2004
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)

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