Cleared Traditional

RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4

K050125 · More Diagnostics · Toxicology
Mar 2005
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K050125 is an FDA 510(k) clearance for the RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on March 18, 2005, 58 days after receiving the submission on January 19, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K050125 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2005
Decision Date March 18, 2005
Days to Decision 58 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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