Cleared Traditional

CENTRIFICHEM BUN

K800128 · Union Carbide Corp. · Chemistry
Feb 1980
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K800128 is an FDA 510(k) clearance for the CENTRIFICHEM BUN, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980, 26 days after receiving the submission on January 18, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K800128 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1980
Decision Date February 13, 1980
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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