Cleared Traditional

Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets

K151395 · Immunalysis Corporation · Toxicology
Jul 2015
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K151395 is an FDA 510(k) clearance for the Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on July 24, 2015, 59 days after receiving the submission on May 26, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K151395 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2015
Decision Date July 24, 2015
Days to Decision 59 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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