Cleared Traditional

ALBUMIN

K850931 · Dilab, Inc. · Chemistry
Jun 1985
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K850931 is an FDA 510(k) clearance for the ALBUMIN, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 26, 1985, 111 days after receiving the submission on March 7, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K850931 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1985
Decision Date June 26, 1985
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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