K-number	K905828
Device name	ABUSCREEN(R) ONLINE CALIBRATORS
Applicant	Roche Diagnostic Systems, Inc.
Product code	DKB
Device class	Class II
Decision date	Feb 4, 1991
Decision	Substantially Equivalent
Regulation	862.3200

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View the full FDA submission: accessdata.fda.gov

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ABUSCREEN(R) ONLINE CALIBRATORS

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