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510(k) K972618

QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) by Phamatech — Product Code DMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1997
Date Received
July 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Cocaine
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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Other clearances for product code DMN

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