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510(k) K013180

RAPIDONE-ECSTASY TEST by American Bio Medica Corp. — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2001
Date Received
September 24, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

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  • K041696 — RAPID READER (July 12, 2005)
  • K041712 — 'RAPIDTEC 4' TEST (November 3, 2004)
  • 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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