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510(k) K012159

RAPID DRUG SCREEN by American Bio Medica Corp. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2001
Date Received
June 22, 2001
Clearance Type
Special
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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