FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX COCAINE METABOLITE
K Number: K113751
·
Decision May 8, 2012
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
116
Review Days
139
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Basic Information
- Device Name
- RANDOX COCAINE METABOLITE
- K Number
- K113751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- December 21, 2011
- Decision Date
- May 8, 2012
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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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