Cleared Traditional

UREA

K971309 · Derma Media Lab., Inc. · Chemistry
Aug 1997
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K971309 is an FDA 510(k) clearance for the UREA, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on August 1, 1997, 115 days after receiving the submission on April 8, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K971309 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1997
Decision Date August 01, 1997
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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