Cleared Traditional

LIQUILYME BUN REAGENT

K812945 · Amresco, Inc. · Chemistry
Nov 1981
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K812945 is an FDA 510(k) clearance for the LIQUILYME BUN REAGENT, a Conductivity Rate, Urea Nitrogen (Class II — Special Controls, product code LFP), submitted by Amresco, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981, 17 days after receiving the submission on October 20, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K812945 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1981
Decision Date November 06, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LFP — Conductivity Rate, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770