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510(k) K023184

ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM by Bayer Diagnostics Corp. — Product Code DIC

K023184 is an FDA 510(k) premarket notification submitted by Bayer Diagnostics Corp. for the device "ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 18, 2002. The device falls under product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method), a Class II device regulated under 21 CFR 862.3040. Bayer Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2002
Date Received
September 24, 2002
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 Bayer Diagnostics Corp.

  • K033379 — BAYER SPECIAL CHEMISTRY CONTROLS (December 19, 2003)
  • K033380 — BAYER SPECIAL CHEMISTRY CALIBRATORS (December 16, 2003)
  • K033007 — BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (November 14, 2003)
  • K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (September 4, 2003)
  • K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (March 18, 2003)
  • K030452 — BAYER LIGAND PLUS 1, 2, 3 CONTROLS (March 3, 2003)
  • K023840 — ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (January 7, 2003)
  • K023841 — AMMONIA ASSAY FOR THE ADVIA 1650 (December 24, 2002)
  • K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 17, 2002)
  • K022329 — CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (November 27, 2002)

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)
  • K070853 — DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 (June 13, 2007)

FDA data resources