Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)— 510(k) K152269

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K152269 for Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card), Substantially Equivalent on 2015-09-09. Applicant: Healgen Scientific,, LLC.

Clearance details

Applicant: Healgen Scientific,, LLC
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 2015-08-11
Decision date: 2015-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellaire, TX, US

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