Cleared Traditional

Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set

K151203 · Immunalysis Corporation · Toxicology
Jun 2015
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K151203 is an FDA 510(k) clearance for the Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on June 5, 2015, 31 days after receiving the submission on May 5, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K151203 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2015
Decision Date June 05, 2015
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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