RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU— 510(k) K133047
Substantially EquivalentBiophor Diagnostics, Inc.
FDA 510(k) clearance K133047 for RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU, Substantially Equivalent on 2014-12-18. Applicant: Biophor Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biophor Diagnostics, Inc.
- Product code
- Code LAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.