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 EquivalentHealgen 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. Device class: 2.
Clearance details
- Applicant
- Healgen Scientific,, LLC
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellaire, TX, US
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More clearances from Healgen Scientific,, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.