Home / 510(k) Clearances / K223324

510(k) K223324

Total Bilirubin2 by Abbott Ireland Diagnostics Division — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2022
Date Received
October 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type

Other clearances by Abbott Ireland Diagnostics Division

  • K223317 — Alkaline Phosphatase2 (July 21, 2023)
  • K203597 — Cholesterol2 (June 30, 2022)
  • K203771 — Urea Nitrogen2 (May 31, 2022)
  • K210633 — Amylase2 (May 26, 2022)
  • K210452 — Creatinine2 (March 22, 2022)
  • K203530 — Albumin BCP2 (March 18, 2022)
  • K203248 — Albumin BCG2 (November 23, 2021)

Other clearances for product code CIG

  • K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) (February 27, 2026)
  • K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil) (June 12, 2023)
  • K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil) (March 20, 2023)
  • K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides (April 26, 2019)
  • K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN (July 11, 2017)
  • K150510 — Total Bilirubin (April 2, 2015)
  • K131544 — COBAS C BILIRUBIN TOTAL GEN.3 (July 17, 2013)
  • K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (June 7, 2013)
  • K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (March 1, 2013)
  • K123965 — COBAS INTEGRA BILIRUBIN DIRECT GEN.2 (February 28, 2013)