Cleared Traditional

DIRECT UREA NITROGEN TEST

K780262 · Hycel, Inc. · Chemistry
Apr 1978
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K780262 is an FDA 510(k) clearance for the DIRECT UREA NITROGEN TEST, a Diacetyl-monoxime, Urea Nitrogen (Class II — Special Controls, product code CDW), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1978, 47 days after receiving the submission on February 17, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K780262 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 1978
Decision Date April 05, 1978
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDW — Diacetyl-monoxime, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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