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510(k) K992452

RAPIDONE-AMPHETAMINE TEST by American Bio Medica Corp. — Product Code DOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1999
Date Received
July 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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