Home / 510(k) Clearances / K973995

510(k) K973995

RANDOX BILIRUBIN by Randox Laboratories, Ltd. — Product Code GIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1997
Date Received
October 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobinometer
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

Other clearances by Randox Laboratories, Ltd.

  • DEN240035 — ConcizuTrace™ ELISA (May 22, 2025)
  • 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 GIG

  • K933836 — HBM HEMOGLOBINOMETER (March 31, 1994)
  • K771101 — HEMOGLOBIN ANALYZER & PERFORM. CHECK SET (July 21, 1977)