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510(k) K013538

ETHANOL by Abbott Laboratories — Product Code DML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2001
Date Received
October 24, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

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Other clearances for product code DML

  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K963197 — ON.SITE ALCOHOL (September 19, 1996)
  • K953765 — AXSYM REA ETHANOL (September 27, 1995)
  • K952839 — BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY (August 24, 1995)
  • K923337 — ON*SITE ALCOHOL (January 12, 1993)
  • K914777 — SIGMA PROCEDURE NO. 333-UV (December 27, 1991)
  • K874382 — RAICHEM(TM) ALCOHOL REAGENT (January 11, 1988)
  • K872180 — KINETIC 610 ETHANOL (July 7, 1987)
  • K863419 — EMDS(TM) ALCOHOL TESTPACKS, #67691/95 (September 29, 1986)
  • K840769 — PARAMAX ALCOHOL REAGENT (April 13, 1984)