Cleared Traditional

THERACHEM, TDC THERAPEUTIC DRUG CONTROLS

K860919 · Fisher Scientific Co., LLC · Toxicology
Apr 1986
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K860919 is an FDA 510(k) clearance for the THERACHEM, TDC THERAPEUTIC DRUG CONTROLS, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Fisher Scientific Co., LLC (Orangeburg, US). The FDA issued a Cleared decision on April 11, 1986, 31 days after receiving the submission on March 11, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K860919 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1986
Decision Date April 11, 1986
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

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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