RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET— 510(k) K141748
Substantially EquivalentBiophor Diagnostics, Inc.
FDA 510(k) clearance K141748 for RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET, Substantially Equivalent on 2015-05-20. Applicant: Biophor Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biophor Diagnostics, Inc.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
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