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510(k) K111206

TECO DIAGNOSTICS SALIVA ALCOHOL TEST by Teco Diagnostics — Product Code DIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2011
Date Received
April 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

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Other clearances for product code DIC

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  • K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (November 15, 2011)
  • K092273 — RANDOX ETHANOL ASSAY (November 1, 2010)
  • K093879 — MISSION SALIVA ALCOHOL TEST STRIP (August 6, 2010)
  • K071811 — ETOH FLEX REAGENT CARTRIDGE (DF22) (August 24, 2007)
  • K070853 — DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 (June 13, 2007)
  • K061792 — DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FL (July 18, 2006)