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510(k) K063015

AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 by Ameditech, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2006
Date Received
October 2, 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 Ameditech, Inc.

  • K113501 — AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) (December 5, 2011)
  • K113046 — AMEDITECH IMMUTEST MILTI-DRUG SCREEN (November 10, 2011)
  • K053175 — AMEDITECH DRUGSMARTCUP (December 8, 2005)
  • K050186 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III (March 4, 2005)
  • K042975 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II (December 29, 2004)
  • K040092 — AMEDITECH IMMU TEST DRUG SCREEN PANEL (March 8, 2004)
  • K023126 — AMEDITECH IMMUTEST HCG PREGANCY TEST (November 18, 2002)
  • K012582 — AMEDITECH IMMUTEST DRUG SCREEN PCP (November 30, 2001)
  • K012484 — AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE (November 30, 2001)
  • K012483 — AMEDITECH IMMUTEST DRUG SCREEN OPIATES (November 30, 2001)

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