Cleared Traditional

QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL

K861420 · Quantimetrix Corp. · Chemistry
Sep 1986
Decision
154d
Days
Class 1
Risk

About This 510(k) Submission

K861420 is an FDA 510(k) clearance for the QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on September 16, 1986, 154 days after receiving the submission on April 15, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K861420 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1986
Decision Date September 16, 1986
Days to Decision 154 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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