Cleared Traditional

LITHIUM REAGENT

K841847 · Reagent Laboratory, Inc. · Toxicology
Aug 1984
Decision
121d
Days
Class 1
Risk

About This 510(k) Submission

K841847 is an FDA 510(k) clearance for the LITHIUM REAGENT, a Flame Emission Photometer For Clinical Use (Class I — General Controls, product code JJO), submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984, 121 days after receiving the submission on April 18, 1984. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2540.

Submission Details

510(k) Number K841847 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1984
Decision Date August 17, 1984
Days to Decision 121 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code JJO — Flame Emission Photometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2540