Home / 510(k) Clearances / K854723

510(k) K854723

SKD ELECTROCHEMICAL SYSTEM (ECS) by Smithkline Diagnostics, Inc. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1986
Date Received
November 22, 1985
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 Smithkline Diagnostics, Inc.

  • K961062 — FLEXSURE OBT (November 6, 1996)
  • K960183 — FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS F (June 7, 1996)
  • K934863 — FLEXSURE HP (May 18, 1994)
  • K880499 — HEMOCCULT SENSITIVE TEST (May 23, 1988)
  • K875131 — (SKD) CHOLESTEROL TEST KIT (March 1, 1988)
  • K862849 — HEMOCCULT WIPE TEST (December 9, 1986)
  • K852841 — RAPID DIRECT STREP A LATEX AGGLUTINATION TEST (July 24, 1985)
  • K821884 — GASTROCCULT TM (October 8, 1982)
  • K821674 — SPINCHEM ACID PHOSPHATASE REAGENT (June 22, 1982)
  • K821184 — SPIN CHEM REAGENTS & STANDARDS (May 24, 1982)

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)
  • K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (October 1, 2020)
  • 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)