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510(k) K864894

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

K864894 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93". The FDA issued a decision of Substantially Equivalent on January 9, 1987. The device falls under product code DMT (Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet), a Class II device regulated under 21 CFR 862.3040. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

Other clearances for product code DMT

  • K000410 — SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS (April 10, 2000)
  • 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)

FDA data resources