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510(k) K970579

ONE STEP MORPHINE CARD TEST by Teco Diagnostics — Product Code DNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1997
Date Received
February 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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