Cleared Traditional

ESA LEADCARE II LEAD CONTROL

K063398 · Bionostics, Inc. · Toxicology
Dec 2006
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K063398 is an FDA 510(k) clearance for the ESA LEADCARE II LEAD CONTROL, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on December 5, 2006, 26 days after receiving the submission on November 9, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K063398 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2006
Decision Date December 05, 2006
Days to Decision 26 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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