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510(k) K923783

ETHYL ALCOHOL ASSAY by Diagnostic Reagents, Inc. — Product Code DMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1993
Date Received
July 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

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Other clearances for product code DMT

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  • K934273 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) (March 21, 1994)
  • K864894 — EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 (January 9, 1987)
  • K843378 — ETHYL ALCOHOL ASSAY KIT (September 14, 1984)
  • K810467 — EMIT-ST SERUM ETHYL ALCOHOL ASSAY (March 6, 1981)
  • K802621 — EMIT-STM ETHYL ALCOHOL ASSAY (October 31, 1980)