Cleared Traditional

Albumin BCP2

K203530 · Abbott Ireland Diagnostics Division · Chemistry
Mar 2022
Decision
471d
Days
Class 2
Risk

About This 510(k) Submission

K203530 is an FDA 510(k) clearance for the Albumin BCP2, a Bromcresol Purple Dye-binding, Albumin (Class II — Special Controls, product code CJW), submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on March 18, 2022, 471 days after receiving the submission on December 2, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K203530 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2020
Decision Date March 18, 2022
Days to Decision 471 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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