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510(k) K200544

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

K200544 is an FDA 510(k) premarket notification submitted by Diamond Diagnostics, Inc. for the device "SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+". The FDA issued a decision of Substantially Equivalent on October 1, 2020. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Diamond Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K133751 — DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS (August 8, 2014)
  • K124009 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAY (April 17, 2013)
  • 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)

Other clearances for product code CEM

  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K241037 — ABL90 FLEX PLUS System (January 14, 2025)
  • K220396 — EasyStat 300 (September 26, 2023)
  • K230890 — ISE Electrodes (September 8, 2023)
  • K121012 — FLEXLAB 3.6, ACCELERATOR A3600 (August 31, 2012)
  • K121040 — SMARTLYTE ELECTROLYTE ANALYZER (August 30, 2012)
  • K112995 — GEM PREMIER 4000 (May 3, 2012)
  • K110520 — BIOLIS 12I (March 23, 2012)
  • K112412 — AU5800(R) CHEMISTRY ANALYZER (December 23, 2011)
  • K112408 — POLY-CHEM 90 ISE MODULE (November 4, 2011)

FDA data resources