Cleared Traditional

FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814

K871320 · American Research Products Co. · Chemistry
Apr 1987
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K871320 is an FDA 510(k) clearance for the FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814, 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 April 22, 1987, 19 days after receiving the submission on April 3, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K871320 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1987
Decision Date April 22, 1987
Days to Decision 19 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