K-number	K911626
Device name	SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER
Applicant	Serono Baker Diagnostics System
Product code	GKZ
Device class	Class II
Decision date	Sep 13, 1991
Decision	Substantially Equivalent
Regulation	864.5220

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View the full FDA submission: accessdata.fda.gov

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SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER

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