FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
K Number: K080436
·
Decision Feb 11, 2009
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
144
Applicant Total
4
Review Days
358
Basic Information
- Device Name
- RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
- K Number
- K080436
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- QUANTRX BIOMEDICAL CORPORATION
- Date Received
- February 19, 2008
- Decision Date
- February 11, 2009
- 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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Other Clearances by QUANTRX BIOMEDICAL CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K080431 | RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 | Jan 8, 2009 | Substantially Equivalent |
| K080455 | RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 | Dec 31, 2008 | Substantially Equivalent |
| K070484 | QUANTRX FEMALE FERTILITY TEST | Oct 22, 2007 | Substantially Equivalent |