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510(k) K993796

RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE by American Bio Medica Corp. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
November 9, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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  • K023869 — 'RAPIDTEC'-5M-MULTIPLE DIP TEST (April 30, 2003)
  • K021114 — 'RAPIDTEC' 5A MULTIPLE DIP TEST (July 23, 2002)

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