Cleared Traditional

UREAFAST

K863076 · J. D. Assoc. · Chemistry
Sep 1986
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K863076 is an FDA 510(k) clearance for the UREAFAST, a Berthelot Indophenol, Urea Nitrogen (Class II — Special Controls, product code CDL), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 9, 1986, 28 days after receiving the submission on August 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K863076 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1986
Decision Date September 09, 1986
Days to Decision 28 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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