RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
FDA 510(k) clearance K132096 · decided 2013-10-18
Clearance details
- K-number
- K132096
- Device name
- RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
- Applicant
- Biophor Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-08
- Decision date
- 2013-10-18
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- LDJ
- Device class
- 2
- Regulation number
- 862.3870
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.