K-number	K946000
Device name	ABUSCREEN ONLINE(R) CALIBRATORS
Applicant	Roche Diagnostic Systems, Inc.
Product code	DKJ
Device class	Class II
Decision date	Jan 25, 1995
Decision	Substantially Equivalent
Regulation	862.3830

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View the full FDA submission: accessdata.fda.gov

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ABUSCREEN ONLINE(R) CALIBRATORS

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