Cleared Traditional

VOLUME TEST DYE 6

K841422 · Reagent Laboratory, Inc. · Chemistry
May 1984
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K841422 is an FDA 510(k) clearance for the VOLUME TEST DYE 6, 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 May 11, 1984, 36 days after receiving the submission on April 5, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2540.

Submission Details

510(k) Number K841422 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1984
Decision Date May 11, 1984
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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