Cleared Traditional

Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

K150791 · Healgen Scientific, LLC · Toxicology
Apr 2015
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K150791 is an FDA 510(k) clearance for the Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card), a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on April 24, 2015, 30 days after receiving the submission on March 25, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K150791 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2015
Decision Date April 24, 2015
Days to Decision 30 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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