FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
K Number: K141748
·
Decision May 20, 2015
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
7
Review Days
324
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Basic Information
- Device Name
- RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
- K Number
- K141748
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biophor Diagnostics, Inc.
- Date Received
- June 30, 2014
- Decision Date
- May 20, 2015
- Product Code
- DKZ
- 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | FDA class 2 | Clinical Toxicology |
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Other Clearances by Biophor Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls | Sep 18, 2015 | Substantially Equivalent |
| K142129 | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET | Jul 24, 2015 | Substantially Equivalent |
| K133047 | RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU | Dec 18, 2014 | Substantially Equivalent |
| K133642 | RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK | Jan 24, 2014 | Substantially Equivalent |
| K132096 | RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR | Oct 18, 2013 | Substantially Equivalent |
| K122703 | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR | Apr 25, 2013 | Substantially Equivalent |