Cleared Traditional

Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set

K150925 · Immunalysis Corporation · Toxicology
Jun 2015
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K150925 is an FDA 510(k) clearance for the Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on June 29, 2015, 84 days after receiving the submission on April 6, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K150925 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2015
Decision Date June 29, 2015
Days to Decision 84 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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