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510(k) K103373

SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 by Beckman Coulter, Inc. — Product Code DIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2011
Date Received
November 17, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Cholinesterase
Device Class
Class I
Regulation Number
862.3240
Review Panel
TX
Submission Type

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Other clearances for product code DIH

  • K061093 — CHOLINESTERASE GEN.2 TEST SYSTEM (July 3, 2006)
  • K051444 — SENTINEL CHOLINESTERASE LIQUID (June 20, 2005)
  • K030045 — OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) (February 21, 2003)
  • K023992 — WIENER LAB COLINESTERASA AA (February 12, 2003)
  • K013750 — ADVIA 1650 CHOLINESTERASE ASSAY (January 18, 2002)
  • K002792 — CARESIDE CHOLINESTERASE (November 8, 2000)
  • K001344 — ADVIA IMS (June 26, 2000)
  • K961656 — TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (November 26, 1996)
  • K943367 — IL TEST CHOLINESTERASE (February 5, 1996)
  • K955498 — CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 (January 24, 1996)