Name: Predicase
Price: 199 USD

K-number	K010765
Device name	COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
Applicant	Beckman Coulter, Inc.
Product code	GKZ
Device class	Class II
Decision date	Apr 13, 2001
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526

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