Cleared Traditional

ALBUMIN REAGENT SET

K905776 · Biochemical Trade, Inc. · Toxicology
Feb 1991
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K905776 is an FDA 510(k) clearance for the ALBUMIN REAGENT SET, a Bromcresol Purple Dye-binding, Albumin (Class II — Special Controls, product code CJW), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on February 26, 1991, 61 days after receiving the submission on December 27, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K905776 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1990
Decision Date February 26, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

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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