Cleared Traditional

QUANTIMETRIX DRUG FREE SERUM CONTROL

K863388 · Quantimetrix Corp. · Toxicology
Sep 1986
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K863388 is an FDA 510(k) clearance for the QUANTIMETRIX DRUG FREE SERUM CONTROL, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on September 29, 1986, 26 days after receiving the submission on September 3, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K863388 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1986
Decision Date September 29, 1986
Days to Decision 26 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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