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510(k) K244042

Calcium2 by Abbott Ireland — Product Code CJY

K244042 is an FDA 510(k) premarket notification submitted by Abbott Ireland for the device "Calcium2". The FDA issued a decision of Substantially Equivalent on February 10, 2025. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Abbott Ireland has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2025
Date Received
December 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Abbott Ireland

  • K252357 — Glucose2 (October 24, 2025)

Other clearances for product code CJY

  • K191396 — Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (July 26, 2019)
  • K182042 — Randox Calcium (Ca) (October 23, 2018)
  • K151113 — ELITech Clinical Systems CALCIUM ARSENAZO (July 22, 2015)
  • K123171 — ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX (July 3, 2013)
  • K120626 — EON CALCIUM REGENT (August 22, 2012)
  • K083386 — ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 0 (April 2, 2009)
  • K072356 — S-TEST CA (June 24, 2008)
  • K073355 — CALCIUM, SCAL, NORTROL, ABTROL (February 28, 2008)
  • K072443 — VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (September 24, 2007)
  • K072440 — VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL (September 20, 2007)

FDA data resources