DeviceClearance

Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)— 510(k) K150791

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K150791 for Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card), Substantially Equivalent on 2015-04-24. Applicant: Healgen Scientific,, LLC.

Clearance details

Applicant
Healgen Scientific,, LLC
Product code
Code DIS
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bellaire, TX, US
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