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510(k) K961656

TEST-MATE CHE CHOLINESTERASE TEST SYSTEM by Eqm Research, Inc. — Product Code DIH

K961656 is an FDA 510(k) premarket notification submitted by Eqm Research, Inc. for the device "TEST-MATE CHE CHOLINESTERASE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 1996. The device falls under product code DIH (Colorimetry, Cholinesterase), a Class I device regulated under 21 CFR 862.3240.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1996
Date Received
April 30, 1996
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

Other clearances for product code DIH

  • K103373 — SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (February 7, 2011)
  • 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)
  • K943367 — IL TEST CHOLINESTERASE (February 5, 1996)
  • K955498 — CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 (January 24, 1996)

FDA data resources