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510(k) K963197

ON.SITE ALCOHOL by Ansys, Inc. — Product Code DML

K963197 is an FDA 510(k) premarket notification submitted by Ansys, Inc. for the device "ON.SITE ALCOHOL". The FDA issued a decision of Substantially Equivalent on September 19, 1996. The device falls under product code DML (Nad-Nadh, Specific Reagent For Alcohol Enzyme Method), a Class II device regulated under 21 CFR 862.3040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1996
Date Received
August 15, 1996
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 for product code DML

  • K013538 — ETHANOL (December 14, 2001)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • 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)

FDA data resources