Cleared Traditional

Albumin BCG2

K203248 · Abbott Ireland Diagnostics Division · Chemistry
Nov 2021
Decision
384d
Days
Class 2
Risk

About This 510(k) Submission

K203248 is an FDA 510(k) clearance for the Albumin BCG2, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on November 23, 2021, 384 days after receiving the submission on November 4, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K203248 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2020
Decision Date November 23, 2021
Days to Decision 384 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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