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510(k) K042975

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

K042975 is an FDA 510(k) premarket notification submitted by Ameditech, Inc. for the device "AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II". The FDA issued a decision of Substantially Equivalent on December 29, 2004. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Ameditech, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K012483 — AMEDITECH IMMUTEST DRUG SCREEN OPIATES (November 30, 2001)
  • K012484 — AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE (November 30, 2001)

Other clearances for product code DIS

  • K161714 — Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibr (October 14, 2016)
  • K151211 — AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbit (June 4, 2015)
  • K150791 — Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphin (April 24, 2015)
  • K143535 — CR3 Keyless Split Sample Cup Secobarbital- Methadone (January 13, 2015)
  • K140665 — GenPrime Snap-Top Split Key Cup (December 8, 2014)
  • K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD (June 16, 2014)
  • K092268 — RANDOX BARITURATES ASSAY (May 25, 2011)
  • K110515 — UCP DRUG SCREENING TEST CUPS (April 20, 2011)
  • K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X (December 7, 2007)
  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)

FDA data resources