OralTox Oral fluid Drug Test— 510(k) K181305
Substantially EquivalentPremier Biotech, Inc.
FDA 510(k) clearance K181305 for OralTox Oral fluid Drug Test, Substantially Equivalent on 2018-09-20. Applicant: Premier Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Premier Biotech, Inc.
- Product code
- Code DJC
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.