Cleared Traditional

THERACHEM TDC THERAPEUTIC DRUG CONTROL

K840921 · Fisher Diagnostics · Toxicology
Apr 1984
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K840921 is an FDA 510(k) clearance for the THERACHEM TDC THERAPEUTIC DRUG CONTROL, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Fisher Diagnostics (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984, 34 days after receiving the submission on March 2, 1984. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K840921 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1984
Decision Date April 05, 1984
Days to Decision 34 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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