Cleared Traditional

BUN

K971967 · Carolina Liquid Chemistries Corp. · Chemistry
Jun 1997
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K971967 is an FDA 510(k) clearance for the BUN, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 17, 1997, 20 days after receiving the submission on May 28, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K971967 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1997
Decision Date June 17, 1997
Days to Decision 20 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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