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510(k) K971506

SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR by Beckman Instruments, Inc. — Product Code DMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
April 25, 1997
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

  • K000410 — SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS (April 10, 2000)
  • K934273 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) (March 21, 1994)
  • K923783 — ETHYL ALCOHOL ASSAY (January 21, 1993)
  • 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)