RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
FDA 510(k) clearance K122703 · decided 2013-04-25
Clearance details
- K-number
- K122703
- Device name
- RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
- Applicant
- Biophor Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-04
- Decision date
- 2013-04-25
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- LCM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.