Cleared Traditional

COLORIMETRIC BUN REAGENT KIT

K871651 · Biochemical Trade, Inc. · Chemistry
May 1987
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K871651 is an FDA 510(k) clearance for the COLORIMETRIC BUN REAGENT KIT, a Berthelot Indophenol, Urea Nitrogen (Class II — Special Controls, product code CDL), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on May 12, 1987, 14 days after receiving the submission on April 28, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K871651 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1987
Decision Date May 12, 1987
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDL — Berthelot Indophenol, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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