Cleared Traditional

ALBUMIN REAGENT

K021636 · Intersect Systems, Inc. · Chemistry
Jul 2002
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K021636 is an FDA 510(k) clearance for the ALBUMIN REAGENT, a Bromcresol Purple Dye-binding, Albumin (Class II — Special Controls, product code CJW), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on July 17, 2002, 61 days after receiving the submission on May 17, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K021636 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2002
Decision Date July 17, 2002
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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