Cleared Traditional

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806

K925550 · Hichem Diagnostics · Chemistry
Apr 1993
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K925550 is an FDA 510(k) clearance for the HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806, a Electrode, Ion Specific, Urea Nitrogen (Class II — Special Controls, product code CDS), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on April 20, 1993, 168 days after receiving the submission on November 3, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K925550 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1992
Decision Date April 20, 1993
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDS — Electrode, Ion Specific, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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