Cleared Traditional

DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE

K914507 · Diagnostic Products Corp. · Toxicology
Dec 1991
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K914507 is an FDA 510(k) clearance for the DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE, a Radioimmunoassay, Cannabinoid(s) (Class II — Special Controls, product code LAT), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 18, 1991, 70 days after receiving the submission on October 9, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K914507 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 1991
Decision Date December 18, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LAT — Radioimmunoassay, Cannabinoid(s)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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