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510(k) K203530

Albumin BCP2 by Abbott Ireland Diagnostics Division — Product Code CJW

K203530 is an FDA 510(k) premarket notification submitted by Abbott Ireland Diagnostics Division for the device "Albumin BCP2". The FDA issued a decision of Substantially Equivalent on March 18, 2022. The device falls under product code CJW (Bromcresol Purple 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
March 18, 2022
Date Received
December 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Purple 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)
  • K203248 — Albumin BCG2 (November 23, 2021)

Other clearances for product code CJW

  • K193001 — Albumin BCP (December 19, 2019)
  • K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRAT (October 16, 2013)
  • K021636 — ALBUMIN REAGENT (July 17, 2002)
  • K000483 — RANDOX ALBUMIN (March 31, 2000)
  • K990978 — ALBUMIN BCG, MODEL AL 103-01 (May 25, 1999)
  • K981814 — ALBP (July 22, 1998)
  • K981457 — ALBP (May 27, 1998)
  • K913025 — ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (October 9, 1991)
  • K905776 — ALBUMIN REAGENT SET (February 26, 1991)
  • K863226 — ALBUMIN (BCP) (September 17, 1986)

FDA data resources