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510(k) K042975

AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II by Ameditech, Inc. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2004
Date Received
October 28, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
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)
  • 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)
  • 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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  • K092268 — RANDOX BARITURATES ASSAY (May 25, 2011)
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  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)
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