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510(k) K203248

Albumin BCG2 by Abbott Ireland Diagnostics Division — Product Code CIX

K203248 is an FDA 510(k) premarket notification submitted by Abbott Ireland Diagnostics Division for the device "Albumin BCG2". The FDA issued a decision of Substantially Equivalent on November 23, 2021. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Abbott Ireland Diagnostics Division has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2021
Date Received
November 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

Other clearances by Abbott Ireland Diagnostics Division

  • K223317 — Alkaline Phosphatase2 (July 21, 2023)
  • K223324 — Total Bilirubin2 (December 29, 2022)
  • 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)

Other clearances for product code CIX

  • K251157 — Core Metabolic (January 9, 2026)
  • K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medic (September 21, 2021)
  • K191316 — VITROS XT Chemistry Products ALB-TP Slides (June 7, 2019)
  • K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 (April 13, 2018)
  • K131488 — ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND (August 19, 2013)
  • K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE P (July 13, 2012)
  • K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEI (September 8, 2011)
  • K110830 — ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELI (June 21, 2011)
  • K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (April 4, 2011)
  • K080874 — EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT (February 20, 2009)

FDA data resources