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510(k) K033246

PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS by Roche Diagnostics Corp. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2003
Date Received
October 7, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

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