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510(k) K923337

ON*SITE ALCOHOL by Toxi-Lab, Inc. — Product Code DML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1993
Date Received
June 18, 1992
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

Other clearances by Toxi-Lab, Inc.

  • K932209 — TOXI*LAB LTD OPIATE SYSTEM (September 24, 1993)
  • K903223 — ON-SITE ALCOHOL (March 13, 1991)
  • K901694 — SPEC(TM) EXTRACTION CARTRIDGE (June 1, 1990)
  • K900626 — ALPHA URINE SAMPLE (March 6, 1990)

Other clearances for product code DML

  • K013538 — ETHANOL (December 14, 2001)
  • 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)
  • 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)