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510(k) K860641

EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 by Em Diagnostic Systems, Inc. — Product Code DLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1986
Date Received
February 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Device Class
Class I
Regulation Number
862.3240
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)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST (December 9, 1993)

Other clearances for product code DLI

  • K950180 — DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD (March 15, 1995)
  • K930208 — CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO (April 20, 1993)
  • K860350 — SERUM CHOLINESTERASE REAGENT SET (April 24, 1986)
  • K833062 — SERUM CHOLINESTERASE REAGENT SET (November 25, 1983)
  • K771024 — CHOLINESTERASE REAGENT SYSTEM (July 15, 1977)