Cleared Traditional

Healgen? Accurate Fentanyl Rapid Test Cassette (Urine); Healgen? Accurate Rapid Fentanyl Test Cassette (Urine); Healgen? Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen? Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen? Accurate Fentanyl Rapid Test Strip (Urine); Healgen? Accurate Rapid Fentanyl Test Strip (Urine)

K240949 · Healgen Scientific, LLC · Toxicology
May 2024
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K240949 is an FDA 510(k) clearance for the Healgen? Accurate Fentanyl Rapid Test Cassette (Urine); Healgen? Accurate Rapid Fentanyl Test Cassette (Urine); Healgen? Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen? Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen? Accurate Fentanyl Rapid Test Strip (Urine); Healgen? Accurate Rapid Fentanyl Test Strip (Urine), a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on May 13, 2024, 35 days after receiving the submission on April 8, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K240949 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2024
Decision Date May 13, 2024
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NGL — Test, Opiates, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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