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510(k) K002447

MODIFICATION TO RAPID DRUG SCREEN 9-PANEL by American Bio Medica Corp. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2000
Date Received
August 9, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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