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510(k) K993151

RADID DRUG SCREEN 5-PANEL TEST by American Bio Medica Corp. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2000
Date Received
September 21, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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  • K030835 — 'RAPID ONE' - PROPOXYPHENE TEST (May 22, 2003)
  • K023869 — 'RAPIDTEC'-5M-MULTIPLE DIP TEST (April 30, 2003)
  • K021114 — 'RAPIDTEC' 5A MULTIPLE DIP TEST (July 23, 2002)

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