Cleared Traditional

EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95

K862403 · Diagnostic Systems · Toxicology
Jul 1986
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K862403 is an FDA 510(k) clearance for the EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on July 11, 1986, 15 days after receiving the submission on June 26, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K862403 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1986
Decision Date July 11, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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