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510(k) K040092

AMEDITECH IMMU TEST DRUG SCREEN PANEL by Ameditech, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2004
Date Received
January 16, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Ameditech, Inc.

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  • K063015 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 (December 20, 2006)
  • 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)
  • 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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