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510(k) K200544

SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ by Diamond Diagnostics, Inc. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2020
Date Received
March 3, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

Other clearances by Diamond Diagnostics, Inc.

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  • K121027 — DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH (December 20, 2012)
  • K121040 — SMARTLYTE ELECTROLYTE ANALYZER (August 30, 2012)
  • K121140 — PROLYTE ELECTROLYTE ANALYZER (August 22, 2012)
  • K120591 — DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 (April 17, 2012)
  • K103364 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL (May 6, 2011)
  • K102959 — PROLYTE ELECTROLYTE ANALYZER (January 14, 2011)
  • K093357 — DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE (June 24, 2010)
  • K093492 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBR (March 19, 2010)

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