RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
FDA 510(k) clearance K142129 · decided 2015-07-24
Clearance details
- K-number
- K142129
- Device name
- RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
- Applicant
- Biophor Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-04
- Decision date
- 2015-07-24
- Days to decision
- 354 days
- Clearance type
- Traditional
- Product code
- DIO
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
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| Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (K163570) | Carolina Liquid Chemistries Corporation | 2017-08-15 |
| MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (K162395) | Mp Biomedicals, LLC | 2017-06-02 |
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| SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana (K153646) | Safecare Biotech (Hangzhou) Co., Ltd. | 2016-03-18 |
| Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set (K150925) | Immunalysis Corporation | 2015-06-29 |
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Recalls involving this device
No recalls on record reference this clearance.