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510(k) K070853

DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 by Dade Behring, Inc. — Product Code DIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2007
Date Received
March 28, 2007
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 Dade Behring, Inc.

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  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code DIC

  • K250609 — Sober Self-Test (September 15, 2025)
  • K181553 — Immunalysis Ethyl Alcohol Enzyme Assay (October 31, 2018)
  • K121247 — ALCO-SCREEN (March 22, 2013)
  • 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)
  • K061792 — DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FL (July 18, 2006)