Cleared Traditional

Albumin BCP

K193001 · SENTINEL CH. SpA · Chemistry
Dec 2019
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K193001 is an FDA 510(k) clearance for the Albumin BCP, a Bromcresol Purple Dye-binding, Albumin (Class II — Special Controls, product code CJW), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on December 19, 2019, 52 days after receiving the submission on October 28, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K193001 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2019
Decision Date December 19, 2019
Days to Decision 52 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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