Cleared Traditional

ALBUMIN

K003327 · Jas Diagnostics, Inc. · Chemistry
Dec 2000
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K003327 is an FDA 510(k) clearance for the ALBUMIN, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on December 5, 2000, 42 days after receiving the submission on October 24, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K003327 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2000
Decision Date December 05, 2000
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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