FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
K Number: K142129
·
Decision Jul 24, 2015
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
144
Applicant Total
7
Review Days
354
Basic Information
- Device Name
- RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
- K Number
- K142129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOPHOR DIAGNOSTICS, INC.
- Date Received
- August 4, 2014
- Decision Date
- July 24, 2015
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
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|---|---|---|---|
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