Cleared Traditional

AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346

K863425 · American Research Products Co. · Chemistry
Oct 1986
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K863425 is an FDA 510(k) clearance for the AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346, a Diacetyl-monoxime, Urea Nitrogen (Class II — Special Controls, product code CDW), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on October 1, 1986, 27 days after receiving the submission on September 4, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K863425 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1986
Decision Date October 01, 1986
Days to Decision 27 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