Cleared Traditional

BUN REAGENT

K942984 · American Research Products Co. · Chemistry
Mar 1995
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K942984 is an FDA 510(k) clearance for the BUN REAGENT, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on March 1, 1995, 254 days after receiving the submission on June 20, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K942984 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1994
Decision Date March 01, 1995
Days to Decision 254 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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