Cleared Traditional

K841421 - DAILY WASH SOLUTION 5
(FDA 510(k) Clearance)

May 1984
Decision
36d
Days
Class 1
Risk

K841421 is an FDA 510(k) clearance for the DAILY WASH SOLUTION 5. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.2540.

Submission Details

510(k) Number K841421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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