K-number	K031856
Device name	PRECISET TDM I AND PRECISET TDM II CALIBRATORS
Applicant	Roche Diagnostics Corp.
Product code	DKB
Device class	Class II
Decision date	Aug 6, 2003
Decision	Substantially Equivalent
Regulation	862.3200

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View the full FDA submission: accessdata.fda.gov

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PRECISET TDM I AND PRECISET TDM II CALIBRATORS

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