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510(k) K864894

EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 by Em Diagnostic Systems, Inc. — Product Code DMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1987
Date Received
December 15, 1986
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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  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

Other clearances for product code DMT

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  • K971506 — SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR (June 3, 1997)
  • K934273 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) (March 21, 1994)
  • K923783 — ETHYL ALCOHOL ASSAY (January 21, 1993)
  • 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)