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510(k) K043268

SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 by Randox Laboratories, Ltd. — Product Code CEI

K043268 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2". The FDA issued a decision of Substantially Equivalent on February 15, 2005. The device falls under product code CEI (Uranyl Acetate/Zinc Acetate, Sodium), a Class II device regulated under 21 CFR 862.1665. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2005
Date Received
November 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uranyl Acetate/Zinc Acetate, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by Randox Laboratories, Ltd.

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  • K230890 — ISE Electrodes (September 8, 2023)
  • K182042 — Randox Calcium (Ca) (October 23, 2018)
  • K162200 — Randox RX Daytona Plus Magnesium (MG) (April 28, 2017)
  • K152085 — Liquid CO2-2 (LCO2-2) (February 24, 2016)
  • K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
  • K150654 — Cholesterol (September 29, 2015)
  • K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE ( (January 9, 2014)
  • K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (November 21, 2013)
  • K132156 — RANDOX CSF CONTROLS LEVELS 2 AND 3 (October 23, 2013)

Other clearances for product code CEI

  • K914039 — SODIUM REAGENT SET (October 31, 1991)
  • K902572 — SODIUM REAGENT SET (July 10, 1990)
  • K832552 — SODIUM TEST KIT (September 20, 1983)

FDA data resources