Cleared Traditional

SCOTTS TAP WATER SUBSTITUTE 7

K841423 · Reagent Laboratory, Inc. · Pathology
May 1984
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K841423 is an FDA 510(k) clearance for the SCOTTS TAP WATER SUBSTITUTE 7, a Ph Buffer (Class I — General Controls, product code JCC), submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 22, 1984, 47 days after receiving the submission on April 5, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K841423 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1984
Decision Date May 22, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JCC — Ph Buffer
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010