Cleared Traditional

ATAC PAK ALBUMIN REAGENT

K030006 · Elan Diagnostics · Chemistry
Mar 2003
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K030006 is an FDA 510(k) clearance for the ATAC PAK ALBUMIN REAGENT, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on March 7, 2003, 64 days after receiving the submission on January 2, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K030006 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2003
Decision Date March 07, 2003
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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