RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK— 510(k) K133642
Substantially EquivalentBiophor Diagnostics, Inc.
FDA 510(k) clearance K133642 for RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK, Substantially Equivalent on 2014-01-24. Applicant: Biophor Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biophor Diagnostics, Inc.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- 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.