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510(k) K031856

PRECISET TDM I AND PRECISET TDM II CALIBRATORS by Roche Diagnostics Corp. — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2003
Date Received
June 16, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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