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510(k) K121247

ALCO-SCREEN by Chematics, Inc. — Product Code DIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2013
Date Received
April 25, 2012
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

Other clearances by Chematics, Inc.

  • K121256 — ALCO-SCREEN 02 (September 12, 2012)

Other clearances for product code DIC

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  • K181553 — Immunalysis Ethyl Alcohol Enzyme Assay (October 31, 2018)
  • K121256 — ALCO-SCREEN 02 (September 12, 2012)
  • K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (November 15, 2011)
  • K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST (October 4, 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)