RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR— 510(k) K122703
Substantially EquivalentBiophor Diagnostics, Inc.
FDA 510(k) clearance K122703 for RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR, Substantially Equivalent on 2013-04-25. Applicant: Biophor Diagnostics, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Biophor Diagnostics, Inc.
- Product code
- Code LCM
- Device class
- Unclassified
- Advisory panel
- Unknown
- 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.