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510(k) K060760

RAPIDONE-BUPRENORPHINE TEST by American Bio Medica Corp. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2006
Date Received
March 21, 2006
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

Other clearances by American Bio Medica Corp.

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  • K073078 — RAPID TOX CUP (May 30, 2008)
  • K053422 — RAPIDONE-COCAINE-150 TEST (June 15, 2006)
  • K053359 — RAPIDTOX (May 25, 2006)
  • 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)
  • K014101 — RAPIDONE-OXY TEST (March 20, 2002)

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