Cleared Traditional

ATAC PAK BUN REAGENT

K021385 · Elan Diagnostics · Chemistry
Jul 2002
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K021385 is an FDA 510(k) clearance for the ATAC PAK BUN REAGENT, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on July 12, 2002, 71 days after receiving the submission on May 2, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K021385 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2002
Decision Date July 12, 2002
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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