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510(k) K990409

ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) by Roche Diagnostics Corp. — Product Code DMY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1999
Date Received
February 9, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Morphine
Device Class
Class II
Regulation Number
862.3640
Review Panel
TX
Submission Type

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